How to Choose an AED for Home Use - AED Superstore Resource Center

Choosing a home AED means balancing cost, ease of use, reliability, and long-term maintenance. Focus on total cost of ownership (not just upfront price), user-friendliness, and who the most likely responder will be. Look for trusted brands, check pad and battery replacement cycles, and don’t hesitate to get expert guidance to make the right decision for your household.

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Selecting an automated external defibrillator (AED) for home use can feel overwhelming—but it doesn’t have to be. In this section, we break down the most important factors to consider, from overall cost and device usability to maintenance needs and long-term reliability. Whether you’re buying for peace of mind, caring for someone with a known heart condition, or simply being prepared, this guide will help you choose the right AED for your household. We’ll also share expert tips, common pitfalls.

Key Factors in Choosing an AED

Pricing & Total Cost of Ownership

Home AEDs represent a significant investment; when deciding which AED to buy, consider overall cost of ownership rather than just the sticker price. This includes considering items such as:

• Upfront cost
• Ongoing expenses such as pads and batteries
• AED storage and protection costs
• Accessories
• Desired warranty

Upfront Cost

Of course the advertised price is the obvious starting place. Compare the price offerings for various models and don’t be shy about asking for the best possible price. Coupons and special offers often reduce the purchase price by $200 or more.

Perhaps the initial purchase price is the main limiting factor, in which case there are two obvious home AED choices now available. These AEDs have entry level prices, are available without prescription, and are both of good quality. There are some key differences between the two, however, so give careful attention​​ to selecting the one that best fits the actual end users of the AED purchased. This is where our expert staff can be a great help in making a smart buy.

If the budget allows, it is worth a look at more costly AED models, since models vary in price depending on ruggedness, ease of use, unit design, technical features, and brand reputation. Again, make decisions regarding which unit you want based on the most likely end users of the machine.

Ongoing Expenses

In considering the initial purchase, the batteries and electrode pads necessary to operate the base unit must be included in your thinking. All require periodic replacement, typically once every four to eight years. One might think the batteries and pads would be relatively uniform in shape and installation, like a car battery, but this is unfortunately not the case. They come in many different forms and vary greatly in price; also, some are easier to find and purchase when necessary. On the practical side, some are easier to remove and re-insert at replacement time.

AED Cases and Cabinets

AEDs come in a case, but these vary as well and optional second cases for more protection and convenience if they are to be carried about are available.

Your AED should be kept in a protected place where it can be easily seen when checking its readiness and of course when fetching it for a rescue. Thus a dedicated wall-mounted enclosure, such as an AED cabinet or shelf may be needed.

Desired Accessories

All sorts of items, including signs, stickers, and pre-printed maintenance charts to scissors and razors are available. Be aware that though additional items are made available, they are not needed by every one, especially in home settings.

Extended Warranties & Service Plans

These can save you money in the long run if they cover replacement parts and serve to remind you of regular maintenance dates. Some AEDs can even be linked and/or networked to a computer. This helps assure their proper maintenance to achieve the goal of constant readiness for deployment in an emergency.

Attempted without help, choosing your own AED setup can be confusing and tedious. Starting with a visit to our Cost to Own Chart Tool may help you along with your selection process. Moreover, this is a time when the assistance of one of our sales experts is of great help, and they will be more than willing to guide you in designing a setup tailored to your needs. Relying on them will give you peace of mind and likely save you time and money.

“The most popular Home AED is the Philips OnSite. Customers love it because it’s simple to use, compact, and holds a familiar and trusted name: Philips.” —AEDSuperstore Sales Team

Product Features & Ease of Use

Not all AEDs are created equal when it comes to user-friendliness. Some provide clear voice prompts and visuals, while others come with advanced CPR feedback features for a household setting:

Simple Voice Guidance

Helps even a less-trained rescuer use the AED; calm, straightforward step-by-step instructions reduce panic when seconds count. Some models also come with foreign language prompts, and may even be switchable on the same machine.

CPR Feedback

Immediate proper CPR has been proven crucial in case of an SCA event. This feature helps the first aider to produce effective CPR and offers reassurance to anyone performing chest compressions by guiding depth and rhythm.

Smart Sensors

Smart sensors automatically adjust shock levels based on the patient’s condition.

“The best AED is the one within reach when every second counts. That’s why I chose a Philips Onsite AED for our home. Its simple design and clear audio prompts give me peace of mind, knowing my family is protected.” —Melanie Avendano

Smart Features

Advanced AEDs can test batteries automatically and alert owners when maintenance is required. Warning lights and sounds make checking AED readiness simple and quick. Some models perform daily or weekly full technical self-diagnostics.

Connectivity

A few high-end models can connect to Wi-Fi or apps, sending reminders about pad or battery replacement. They also record data from any use of the machine which can be downloaded to a computer for further use by medical personnel.

Wi-Fi-Connected AEDs

1. ZOLL AED 3 — Offers Wi-Fi connectivity for remote monitoring of battery life, pad status, and readiness.
2. Physio-Control LIFEPAK CR2 — Connects via Wi-Fi or cellular to the LIFELINKcentral AED program manager for tracking readiness.
3. Philips HeartStart FR3 — Can connect via Bluetooth to the Philips HeartStart Event Review software for data transfer.
4. Cardiac Science Powerheart G5 — Has optional connectivity through a USB connection for data transfer but lacks built-in Wi-Fi.

AEDs with App or Bluetooth Connectivity

1. Defibtech Lifeline View — Allows data retrieval via USB or an infrared connection (not direct Wi-Fi).
2. HeartSine Samaritan PAD 450P — Connects to the HeartSine Gateway system (Wi-Fi-based) for tracking readiness.
3. Philips HeartStart FRx — Uses an optional Bluetooth adapter for data reporting.

Customer Service, Support, and Warranty

One of the biggest advantages of buying from a dedicated retailer is the support you’ll receive before and after purchase. At AEDSuperstore, you can expect:

Expert Guidance

Our in-house specialists can recommend models tailored to your specific situation and needs.

Warranty & Returns

We stand by the quality of the products we carry with a 30 day Money Back Guarantee, offering flexible return and warranty options.

Fast Shipping & Setup Assistance

We’ll help you get your AED up and running quickly.

Used vs New AEDs

Money can be saved by purchasing a used AED, but be forewarned. The life-and-death importance of the AED in an SCA rescue makes it crucial that a used unit be refurbished before it is put into use by a new owner. Attention must be given by trained technicians to soundness of the case, condition of the battery and pads, and needed technical inspections/updates before a used AED is returned to service.

Packages vs Individual Unit

We have used our expertise and experience to save you time and money by assembling needed items in packages for use in various settings. Let our experts match you up with just the right AED and accompanying equipment for home use, or, you can simply browse our selection of AED packages for home.

How to Prepare for AED Use and Ownership at Home

Home Storage & Accessibility

You can’t make an AED work effectively if you can’t find or access it during an emergency. We recommend storing it in a central location—often near your main living area or a first-aid cabinet. A visible, easily accessible spot will also make it easier for you to stay aware of your AED and do needed readiness checks consistently.

Wall Mounts & Cases

We offer various cases, cabinets and other storage options to keep your device secure yet easy to reach. Various lights and alarms for a case are available, and we can also help you with ADA guidelines for proper placement (see pages 4 and 5 of the linked document).

Environmental Considerations

As much as possible, avoid extreme heat or dampness when choosing a storage location. If there is a need to place an AED in such a spot (pool house, garage, etc.) proper placement, case, and mounting become even more significant. If you have questions or concerns related to the environment in which the AED will be placed or stored, please let us help you with this step in setting up your AED at home!

Readiness & Basic Use Training

Having an AED at home is just the first step; knowing how to use it is equally crucial. We offer a variety of resources for the home AED machine buyer to help you with proper AED use, maintenance and more.

Tutorials

We can direct you to manufacturer videos or short online courses demonstrating step-by-step operation.

Family Drills

Encourage household members to practice basic steps and know where the AED is stored. Plan regular drills at least quarterly to maintain familiarity with the AED and practice its use. AEDSuperstore offers virtual CPR training, where families can learn about CPR online at their own pace, and then video chat with a licensed American Red Cross CPR trainer for evaluation of their skills.

Liability and Prescription Basics

In most areas, lay rescuers are protected by Good Samaritan laws when providing emergency assistance in good faith. However, it’s worth noting that there is some possible liability for those maintaining an AED in their own home. An AED owner must take proper care of maintaining the AED to help ensure it’s ready to respond during an emergency. This means storing the AED properly, checking the AED monthly (or to the manufacturer’s guidelines) for readiness (pad and battery expiration dates are not near, no visible signs of damage, ready indicator is working), and training responders to use the AED if your state requires it. Failure to have documented records of AED checks or properly maintained accessories leaves you liable if you AED fails to work in an emergency.

OTC vs. Prescription

Some AEDs require a prescription, though certain “home” models are FDA-approved for over-the-counter purchase. There are currently two quality AEDs offered without a prescription:

Philips HeartStart OnSite AED

Key Features

• Voice instructions to guide responders through defibrillation
• CPR coaching for adult or infant/child CPR
• SMART Analysis technology to help determine if shock is needed
• Daily automatic self-tests to check internal circuitry, waveform delivery system, pads and battery capacity
• “Quick Shock” capabilities deliver a shock less than 10 seconds after pausing CPR

HeartSine samaritan 350P Home AED Package

Key features

Contact us to discuss your requirements of Biphasic AED Defibrillator. Our experienced sales team can help you identify the options that best suit your needs.

• Weighs only 2.4 lbs. and is compact
• Easy to follow visual and voice prompts
• Pad-Pak cartridge system that combines the battery and electrode pads
• Durable and rugged design with a dust and water proof IP56 rating
• Large, easy-to-read display that provides clear instructions and feedback
• 8-year battery standby life, which can help save on maintenance costs and ensure device is always ready to use.

Peace of Mind

Remember, AEDs with an “automatic shock” will assess the patient and determine if/when appropriate to administer a shock. The user will not need to push a button, and instead the AED will advise to “step back, do not touch the patient” and will administer the shock for you.

Product Comparisons & Recommendations

We carry a range of AED models suitable for home use. Below are just a few examples, with brief highlights:

Philips HeartStart Home

Price Range: More affordable side
Key Perks: FDA-approved for OTC, straightforward voice prompts, lightweight design
Features

• CPR guidance
• Low AED cost
• Step-by-step voice instructions
• Can be used on adults and children
• Philips HeartStart OnSite AED – 8 year warranty, adult electrode pad cartridge, long-life battery, and quick reference card.
• Philips HeartStart OnSite Pediatric Electrode Pads

ZOLL AED Plus

Price Range: Mid-to-high
Key Perks: CPR feedback mechanism, durable case, good for families with varied skill levels
Features

• Real CPR Help Technology
• Adaptive Metronome
• Durable and Reliable: High IP55 rating
• Extensive Warranty: Seven years of coverage
• ECG Display Upgrade: Available for medical professionals
• One-piece CPR-D™ Padz
• Duracell® Lithium Battery Set, avoiding the need for proprietary batteries

LIFEPAK CR2

Price Range: Higher-end
Key Perks: Rapid shock delivery, optional connectivity for easy maintenance tracking
Features

• Simple—turn on the device by opening the lid and apply the pads
• Clear instructions—auto volume adjusts for background noise
• Bilingual option
• Remote Monitoring
• CPR Coaching
• Escalating power during rescue
• No need for separate Pediatric Electrode Pads
• IP55 rating
• 8-year battery/warranty

Also, please use our comparison chart of available AEDs to help you find a likely choice for your home.

Maintenance & After-Purchase Service

Owning a home AED also means staying on top of battery and pad expiration dates, as well as occasional software updates (for some models).

Reminders & Replacements

AEDSuperstore offers an AED management program called Arch. This handy program provides an interface for you to track your battery and pad expiration dates as well as log your monthly AED checks. With Arch, you’ll receive notifications reminding you to check your AED and notifying you when expiration dates are nearing.

Simple Returns/Exchange

If you ever need a replacement part, we streamline the process.

AEDSuperstore offers a 30-day return for merchandise that is unused and unopened. To start a return, you can reach out to us via , , or chat. Be sure to have your order number handy to make the process go a bit faster.

We want you to feel confident in the life-saving equipment you’ve purchased and are here to help answer any questions you have. Call or chat in during our standard business hours to get in touch with a specialist who can help you troubleshoot, answer questions about set up, and even recommend additional rescue products and training that would work for your situation.

FAQ

1. Do I need a prescription for a home AED?
No, Home AEDs are approved for use with a prescription by the FDA.

2. What if something goes wrong with my AED?
Contact our support team immediately. We can assist with troubleshooting or direct you to the manufacturer.

3. How long do the pads and batteries last?
Pads and batteries each have their own expiration dates to document and keep in mind. Pads are one-time use, and must be disposed of and repurchased if opened (regardless if used on a patient or shock was administered). Expiration windows vary by manufacturer, but typically AED pads expire within 2-3 years, and batteries expire after about 5 years.

4. Where should I store it in my house?
We recommend storing your AED in an easily accessible area that all responders can reach. Often homeowners store their AED in a coat closet, laundry room, or mudroom shelf. Avoid storing in your garage or other non-temperature controlled area, in a closet or room that’s often locked, or is located far away from where the family spends time.

We hope this guide helps you feel more confident about choosing a home AED. Explore our full range of the home AED machines or contact our team for personalized recommendations.

Learn more About AED machines:

• Best AEDs for Home
• How to Use an AED
• AED Cost Calculator – Find the most affordable AEDs

Medical Disclaimer: While we specialize in providing top-quality AEDs and related products, we are not healthcare providers. For detailed medical advice, please consult a qualified medical professional or visit resources like the American Heart Association or the FDA.

Automated external defibrillators (AEDs) are portable, life-saving devices designed to treat people experiencing sudden cardiac arrest, a medical condition in which the heart stops beating suddenly and unexpectedly.

The combination of CPR and early defibrillation is effective in saving lives when used in the first few minutes following a collapse from sudden cardiac arrest.

On this page

• What Are AEDs?
• Check Your AED and AED Accessories: Are They FDA Approved?
• FDA-Approved AEDs
• FDA-Approved AED Accessories
• Important Information for AED and AED Accessory Manufacturers
• The FDA's Continued Efforts to Keep AEDs Reliable

What Are AEDs?

AEDs are a type of computerized defibrillator that automatically analyzes the heart rhythm in people who are experiencing cardiac arrest. When appropriate, it delivers an electrical shock to the heart to restore its normal rhythm. The AED system includes accessories, such as a battery and pad electrodes, that are necessary for the AED to detect and interpret a person's heart rhythm and deliver an electrical shock if one is needed. There are two main types of AEDs: public access and professional use.

• Public access AEDs can be found in airports, community centers, schools, government buildings, hospitals, and other public locations. They are intended to be used by laypeople who have received minimal training.
• Professional use AEDs are used by first responders, such as emergency medical technicians (EMTs) and paramedics, who receive additional AED training.

AEDs can be semi-automated or fully automated.

• Semi-automated defibrillators analyze the heart's rhythm, and if an abnormal heart rhythm is detected that requires a shock, then the device prompts the user to press a button to deliver a defibrillation shock.
• Fully automated defibrillators analyze the heart's rhythm and deliver a defibrillation shock if commanded by the device software without user intervention.

Check Your AED and AED Accessories: Are They FDA Approved?

There are FDA-approved AEDs and AED accessories available, and we encourage you to ensure your AED and AED accessories are FDA-approved; if they are not, we encourage you to transition to FDA-approved AEDs and AED accessories.

If you or your organization owns an AED system, the FDA recommends you:

• Check the tables below to see if your AED system and AED accessories are FDA-approved.
  • FDA-Approved AEDs
  • FDA-Approved AED Accessories
• Contact the manufacturer of your AED or necessary AED accessories if:
  • You are not sure if your AED or AED accessories are FDA-approved or
  • They are not FDA-approved and you have not received a letter from the manufacturer.
• Select and purchase necessary AED accessories directly from authorized retailers to help ensure that you are purchasing an FDA-approved device.
• Locate the unique device identifier (UDI) on the AED or AED accessory product labels before you purchase them and consider searching the UDI in the AccessGUDID Database. The Global Unique Device Identification Database (GUDID) lists most medical devices legally sold in the U.S. from manufacturing through distribution to patient use.
• Continue to keep your AED available for use, even if it is not FDA-approved, until you obtain an FDA- approved AED, given the importance of these devices in emergency situations.
• Be aware that if your AED is not FDA-approved, compatible necessary AED accessories may no longer be available to support your AED after February 3, .
• Report problems with AEDs and AED accessories to the FDA by submitting a voluntary report online at MedWatch.

FDA-Approved AEDs

The table below lists all AEDs that have received premarket approval from the FDA. If your AED is listed below, no matter your purchase date, the AED is considered FDA-approved. The FDA will update this table when new AEDs are approved. For descriptions of these devices, their indications for use, and related information, follow the Premarket Database links.

Important: If your AED is not listed in this table, please contact the manufacturer of your AED for more information about your device.

Manufacturer Device Name Approval Date Premarket Database Avive Solutions, Inc. Avive Automated External Defibrillator (AED) System 10/31/ P Cardiac Science Corporation Powerheart G3 AED 12/07/ P Cardiac Science Corporation Powerheart G3 Plus AED 12/07/ P Cardiac Science Corporation Powerheart G5 AED 12/07/ P Cardiac Science Corporation Powerheart G3 PRO AED 12/06/ P Defibtech, LLC Lifeline/ReviveR DDU-100 02/01/ P Defibtech, LLC Lifeline/ReviveR AUTO DDU-120 02/01/ P Defibtech, LLC Lifeline/ReviveR VIEW DDU- 02/01/ P Defibtech, LLC Lifeline/ReviveR VIEW AUTO DDU- 02/01/ P Defibtech, LLC Lifeline/ReviveR ECG DDU- 02/01/ P Defibtech, LLC Lifeline/ReviveR ECG+ DDU- 02/01/ P HeartSine Technologies, LLC SAM 350P (Samaritan Public Access Automated External Defibrillator) 01/12/ P HeartSine Technologies, LLC SAM 360P (Samaritan Public Access Automated External Defibrillator) 01/12/ P HeartSine Technologies, LLC SAM 450P (Samaritan Public Access Automated External Defibrillator) 01/12/ P HeartSine Technologies, Ltd. samaritan 350P (SAM350P) Automated External Defibrillator 06/23/ P Philips Medical Systems HeartStart Home 06/06/ P Philips Medical Systems HeartStart OnSite 06/06/ P Philips Medical Systems HeartStart FR3 05/11/ P Philips Medical Systems HeartStart FRx 05/11/ P Physio-Control, Inc. LIFEPAK CR Plus Defibrillator 12/21/ P Physio-Control, Inc. LIFEPAK EXPRESS Defibrillator 12/21/ P Physio-Control, Inc. LIFEPAK CR2 Defibrillator 12/21/ P Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillator 07/02/ P Physio-Control, Inc. LIFEPAK 20E Defibrillator/ Monitor 07/02/ P Physio-Control, Inc. LIFEPAK Defibrillator 07/02/ P ZOLL Medical Corporation AED Plus and Fully Automatic AED Plus 05/26/ P ZOLL Medical Corporation X Series Defibrillator 12/27/ P ZOLL Medical Corporation R Series Defibrillator 12/27/ P ZOLL Medical Corporation AED Pro Defibrillator 12/27/ P ZOLL Medical Corporation AED 3 BLS Defibrillator 12/27/ P ZOLL Medical Corporation Propaq MD Defibrillator 12/27/ P ZOLL Medical Corporation AED 3 Defibrillator 02/28/ P/S001

FDA-Approved AED Accessories

The table below lists all necessary AED accessories that have received premarket approval from the FDA and the FDA-approved AED for which it is compatible. The FDA will update this table when new AED accessories are approved.

For more information about the FDA approval of these accessories, their indications for use, and related information, follow the Premarket Database links.

Important: If your AED accessory is not listed in this table, please contact the manufacturer of your accessories for more information about your device.

Manufacturer Accessory Name Compatible AEDs Approval Date Premarket Database AED Battery Exchange -ABE Cardiac Science (now ZOLL) Powerheart G3 02/02/ P AED Battery Exchange G5-ABE Cardiac Science (now ZOLL) Powerheart G5 02/02/ P AED Battery Exchange -ABE Philips HeartStart Onsite/Home (HS1), FRx 02/02/ P AED Battery Exchange FR3-ABE Philips HeartStart FR3 02/02/ P Avive Solutions, Inc. Avive Pad Cartridge Avive AED 10/31/ P Cardiac Science (now ZOLL) Intellisense Lithium Battery (Model , Model -201-TSO) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Pediatric (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/07/ P Cardiac Science (now ZOLL) Intellisense Lithium Battery (ModelXBAED001A, XBTAED005A, XBTAED005A-TSO) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult (Model XELAED001A, XELAED001B, XELAD001C) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Pediatric (Model XELAD003A, XELAD003C) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - ICPR Adult (Model XELAD002B, XELAED002C) Cardiac Science (now ZOLL) Powerheart G5 12/07/ P Cardiac Science (now ZOLL) Intellisense Lithium Battery (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/06/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/06/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Adult - Polarized (Model ) Cardiac Science (now ZOLL) Powerheart G3 Pro 12/06/ P Cardiac Science (now ZOLL) Intellisense Defibrillation Pad - Pediatric (Model ) Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro 12/06/ P Cardinal Health Kendall Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Kendall Adult Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Medi-Trace A Cadence Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Medi-Trace P Cadence Pediatric Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Cardinal Health Medi-Trace PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Medi-Trace R Cadence Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Medi-Trace P Cadence Pediatric Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Medi-Trace PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Medi-Trace R Cadence Adult Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health Kendall P Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 20 and 20E 08/07/ P Cardinal Health Kendall P Adult Multi-Function Defibrillation Electrodes Physio-Control LIFPEAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health Kendall Adult Multi-Function Defibrillation Electrodes ZOLL R Series, X Series, Propaq MD 08/07/ P Cardinal Health QUIK-COMBO Radiotransparent Physio-Control Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Cardinal Health QUIK-COMBO Physio-Control Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Cardinal Health QUIK-COMBO Redi-Pak Preconnect Medtronic Defibrillation Electrode Physio-Control LIFEPAK 15, 20, 20E, , CR Plus, and Express 08/07/ P Cardinal Health QUIK-COMBO RTS Pediatric Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/ P Conmed Adult/Child (radiotransparent) and (radiotranslucent) Physio-Control LIFEPAK 15, 20, and 20E; ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed Adult/Child Model (Sterile) Physio-Control LIFEPAK 15, 20, and 20E; ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed Infant Model and Mini-Infant Model Physio-Control LIFEPAK 15, 20, and 20 E; ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed PadPro Multi-Function Electrode Adaptors (ZMUF, ZMMF) ZOLL R Series, X Series, Propaq MD 09/26/ P Conmed PadPro Multi-Function Electrode Adaptors (MMUF, MMZF) Physio-Control LIFEPAK 15, 20, and 20E 09/26/ P Defibtech DDP-100 Adult Defibrillation Pads Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DDP-200P Pediatric Defibrillation Pads Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DBP- 5 year non-rechargeable battery pack Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DBP- 7 year non-rechargeable battery pack Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/ P/S005 Defibtech DDP- Adult Defibrillation Pads Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 Defibtech DDP- Pediatric Defibrillation Pads Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 Defibtech DBP- 4 year non-rechargeable battery pack Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 Defibtech DBP- 4 year non-rechargeable TSO battery pack Defibtech Lifeline/ReviveR VIEW DDU-, VIEW AUTO DDU-, ECG DDU-, ECG+ DDU- 06/10/ P/S005 HeartSine Pad-Pak-01 (Adult) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/ P HeartSine Pad-Pak-02 (Pediatric) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/ P HeartSine Pad-Pak-7 (Aviation/TSO) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/ P Philips Primary Battery (Model MA) Philips HeartStart Onsite/Home (HS1), FRx 06/06/ P Philips SMART Pads Cartridges (Adult Model MA) Philips HeartStart Onsite/Home (HS1) 06/06/ P Philips SMART Pads Cartridges (Pediatric Model MA) Philips HeartStart Onsite/Home (HS1) 06/06/ P Philips Primary Battery (Models , ) Philips HeartStart FR3 05/11/ P Philips Rechargeable Battery (Model ) Philips HeartStart FR3 05/11/ P Philips Charger for the Rechargeable Battery (Model ) Philips HeartStart FR3 05/11/ P Philips SmartPads III (Models , ) Philips HeartStart FR3 05/11/ P Philips Pediatric Key (Model ) Philips HeartStart FR3 05/11/ P Philips Primary Battery (MA) Philips HeartStart Onsite/Home (HS1), FRx 05/11/ P Philips Aviation FRx Battery () Philips HeartStart FRx 05/11/ P Philips SMART Pads II () Philips HeartStart FRx 05/11/ P Philips Infant/Child Key () Philips HeartStart FRx 05/11/ P Physio-Control CHARGE-PAK Battery Charger Physio-Control LIFEPAK CR Plus and Express 12/21/ P Physio-Control QUICK-STEP Pacing/ECG Defibrillation Electrodes Physio-Control LIFEPAK CR2 12/21/ P Physio-Control LIFEPAK CR2 Lithium Battery Physio-Control LIFEPAK CR2 12/21/ P Physio-Control LIFEPAK Defibrillator Lithium-Ion Rechargeable Battery Physio-Control LIFEPAK 07/02/ P Physio-Control LIFEPAK Defibrillator Non-Rechargeable Battery Physio-Control LIFEPAK 07/02/ P Physio-Control LIFEPAK Lithium-ion Rechargeable Battery Physio-Control LIFEPAK 15 07/02/ P Physio-Control QUIK-COMBO Therapy Cable - Lifepak 20e Physio-Control LIFEPAK 20e 07/02/ P Physio-Control QUIK-COMBO Therapy Cable - Lifepak 15 Physio-Control LIFEPAK 15 07/02/ P Physio-Control QUIK-PAK Electrodes Physio-Control LIFEPAK CR Plus and Express 11/29/ P/S002 Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes Physio-Control LIFEPAK , CR Plus, and Express 07/08/ P/S003 (bundled) Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes Physio-Control LIFEPAK , CR Plus, and Express 07/08/ P/S015 (bundled) ZOLL CPR-D-Padz Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL CPR Stat-Padz Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL Stat-Padz II Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL Pedi-Padz II Electrode ZOLL AED Plus, AED 3 05/26/ P ZOLL AED Plus Aviation Battery Assembly ZOLL AED Plus 05/26/ P ZOLL Pro-Padz Radiotransparent Electrode ZOLL R Series, X Series 12/27/ P ZOLL SurePower Battery Pack ZOLL R Series, AED Pro 12/27/ P ZOLL SurePower II Battery Pack ZOLL X Series, Propaq MD 12/27/ P ZOLL AED Pro Non-Rechargeable Lithium Battery Pack ZOLL AED Pro 12/27/ P ZOLL AED 3 Battery Pack ZOLL AED 3, AED 3 BLS 12/27/ P ZOLL SurePower Charger ZOLL R Series, X Series, Propaq MD, AED Pro 12/27/ P ZOLL SurePower Single Bay Charger ZOLL R Series, X Series, Propaq MD, AED Pro 12/27/ P ZOLL CPR Uni-Padz electrode ZOLL AED 3, AED Plus 02/28/ P/S001 ZOLL AED 3 Battery Pack ZOLL AED 3, AED 3 BLS 02/28/ P/S001 Graphic Controls d.b.a. Nissha Medical Technologies, Vermed, Biomedical Innovations HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads Physio-Control LIFEPAK 15, 20/20e, and ; ZOLL R-Series, X-Series; Cardiac Science (now ZOLL) PowerHeart AED G3 Plus, G3 Pro 06/23/ P ZOLL Pro-padz Sterile Electrodes X Series, Propaq MD, R Series 12/20/ P/S014 ZOLL Stat-padz Electrodes X Series, Propaq MD, R Series, 12/20/ P/S014 ZOLL Stat-padz Deployment Readiness Pack Electrodes X Series, Propaq MD, R Series 12/20/ P/S014 ZOLL Pedi-padz Electrodes X Series, Propaq MD, R Series 12/20/ P/S014 ZOLL Pedi-padz II Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/20/ P/S014 ZOLL Stat-padz II Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/20/ P/S014 ZOLL OneStep CPR Cable R Series 12/20/ P/S014 ZOLL X Series/Propaq MD Multifunction Therapy Cable X Series, Propaq MD 12/20/ P/S014 ZOLL X Series OneStep Cable X Series, Propaq MD 12/20/ P/S014 ZOLL Multifunction Therapy Cable with CPR-D Connector X Series, Propaq MD 12/20/ P/S014 ZOLL OneStep CPR Complete Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep CPR Complete Adult-Child Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Basic Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Pacing Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Pediatric Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep Pediatric CPR Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep CPR II Electrodes R Series 06/21/ P/S015 ZOLL OneStep CPR A/A (Anterior/Anterior) Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL OneStep CPR Electrodes X Series, Propaq MD, R Series 06/21/ P/S015 ZOLL X Series OneStep Cable X Series, Propaq MD 06/21/ P/S015 ZOLL OneStep CPR Cable R Series 06/21/ P/S015 ZOLL R Series OneStep Pacing Cable R Series 06/21/ P/S015 ZOLL X Series/Propaq MD Multifunction Therapy Cable X Series, Propaq MD 06/21/ P/S015 ZOLL Pedi-padz Liquid Gel Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Adult Liquid Gel Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Pro-padz Radiolucent Liquid Gel Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Pro-padz Radiolucent Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL Pedi-padz Radiolucent Electrodes X Series, Propaq MD, R Series 12/19/ P/S016 ZOLL CPR-D-padz Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/19/ P/S016 ZOLL CPR Stat-padz Electrodes X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus 12/19/ P/S016 ZOLL CPR Dura-padz Reusable Electrodes X Series, Propaq MD, R Series, AED Pro 12/19/ P/S016 ZOLL OneStep Cable R Series 12/19/ P/S016 ZOLL OneStep Pacing Cable R Series 12/19/ P/S016 ZOLL R Series MFC (Multifunction Cable) R Series 12/19/ P/S016 ZOLL Multifunction Therapy Cable CPRD Adapter (MFC to CPRD Connector) R Series 12/19/ P/S016 ZOLL CPR Connector X Series, Propaq MD 12/19/ P/S016

Important Information for AED and AED Accessory Manufacturers

To ensure the quality and reliability of AEDs, the FDA requires manufacturers to obtain premarket approval for all AEDs and AED accessories.

The FDA expects that necessary AED accessories will be labeled for use with an FDA-approved AED device (on the list above). Manufacturers submitting a premarket approval application (PMA) for necessary AED accessories should be aware that they can continue to market those accessories while the PMA is pending until the FDA issues a decision (approval, not approvable, or denial decision). After a PMA decision is made, only FDA-approved accessories can continue to be marketed.

The FDA's premarket approval of new and existing AEDs and AED accessories is based on a determination that the application contains sufficient valid scientific evidence to reasonably assure the device is safe and effective for its intended use. This regulatory pathway requires manufacturers to receive FDA approval before initiating design, manufacturing, or labeling changes to the device, and imposes certain annual reporting requirements.

Once the AEDs and AED accessories are on the market, the FDA proactively monitors their safety and reliability by reviewing the manufacturers' manufacturing and design changes, performance reports, and medical device reports (MDRs). When a company initiates a correction or removal action, the FDA posts information about the action in the public Medical Device Recall database. Once classified, the FDA monitors the recall to ensure the recall strategy has been effective.

The FDA's Continued Efforts to Keep AEDs Reliable

The FDA recognizes the importance of AEDs as life-saving devices. Problems associated with AEDs include design and manufacturing issues, such as inadequate control of components purchased from suppliers or inadequate validation of manufacturing processes. When this occurs, an AED can malfunction and may contribute to patient harm or prevent the rescue of the patient.

Given this, the FDA has taken several actions to assure that current and future AEDs and necessary accessories are safe and reliable. These actions include:

• November : The FDA sent letters to AED accessory manufacturers who did not submit a PMA for their AED accessories as required by the final order reminding them that they can no longer market their AED accessories.   
• By February 3, : Manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for the operation of AED systems that are FDA-approved were required to file a premarket approval application (PMA).
• October 27, : FDA revised its compliance policy regarding the deadline for filing a PMA for previously-cleared necessary AED accessories until February 3, . This revised compliance policy allowed health care facilities and manufacturers to remain focused on public health needs related to the COVID-19 public health emergency, while allowing time to transition to FDA-approved AEDs.
• By February 3, : Original date manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for AED systems that are FDA-approved were to file a PMA.
• April : The FDA sent letters to all AED manufacturers, who did not submit a PMA for their AEDs as required by the final order, reminding them they can no longer market their AED; the letters also informed the manufactures that necessary AED accessories may not be marketed after February 3, , if a PMA is not filed. Manufacturers were asked to provide a plan for these AEDs and necessary AED accessories, including a timeline for servicing and phase-out activities, a plan for communicating with their customers, and an estimate of the volume of AEDs and accessories that remain in the field.
• November 1, : The FDA and Philips Medical Systems LLC entered a consent decree of permanent injunction prohibiting Philips Medical Systems, Philips Healthcare, and those individually named from manufacturing, processing, packing, holding, or distributing AEDs from two facilities until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• February : The FDA published a final order in February requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories.
• December : The FDA issued a Safety Communication alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between and that these devices may fail to deliver a shock in the event of an emergency.
• March : The FDA published a proposed order to allow for notice and comment regarding the FDA's recommendation to require premarket approval (PMA) applications for AEDs and necessary AED accessories.
• January : The FDA convened a public meeting of the Circulatory System Device Panel of the Medical Devices Advisory Committee where the FDA presented its comprehensive assessment of AEDs. The panel of independent experts considered the FDA's assessment of AEDs and its recommendation that more stringent FDA oversight be applied to reduce future AED problems. The panel agreed with the FDA's recommendation to require PMA applications for AEDs.