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  5. Automated External Defibrillators (AEDs)
  1. Cardiovascular Devices

Automated External Defibrillators (AEDs)

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.

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What Are AEDs?

Automated External Defibrillator (AED) placed on the wall in a public location.

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.
  • 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, 2022.
  • 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 10/31/2022 P210015
Cardiac Science Corporation Powerheart G3 AED 12/07/2018 P160033
Cardiac Science Corporation Powerheart G3 Plus AED 12/07/2018 P160033
Cardiac Science Corporation Powerheart G5 AED 12/07/2018 P160033
Cardiac Science Corporation Powerheart G3 PRO AED 12/06/2018 P160034
Defibtech, LLC Lifeline/ReviveR DDU-100 02/01/2018 P160032
Defibtech, LLC Lifeline/ReviveR AUTO DDU-120 02/01/2018 P160032
Defibtech, LLC Lifeline/ReviveR VIEW DDU-2300 02/01/2018 P160032
Defibtech, LLC Lifeline/ReviveR VIEW AUTO DDU-2200 02/01/2018 P160032
Defibtech, LLC Lifeline/ReviveR ECG DDU-2450 02/01/2018 P160032
Defibtech, LLC Lifeline/ReviveR ECG+ DDU-2475 02/01/2018 P160032
HeartSine Technologies, LLC SAM 350P (Samaritan Public Access Automated External Defibrillator) 01/12/2017 P160008
HeartSine Technologies, LLC SAM 360P (Samaritan Public Access Automated External Defibrillator) 01/12/2017 P160008
HeartSine Technologies, LLC SAM 450P (Samaritan Public Access Automated External Defibrillator) 01/12/2017 P160008
HeartSine Technologies, Ltd. samaritan 350P (SAM350P) Automated External Defibrillator 06/23/2022 P160008
Philips Medical Systems HeartStart Home 06/06/2019 P160029
Philips Medical Systems HeartStart OnSite 06/06/2019 P160029
Philips Medical Systems HeartStart FR3 05/11/2020 P160028
Philips Medical Systems HeartStart FRx 05/11/2020 P180028
Physio-Control, Inc. LIFEPAK CR Plus Defibrillator 12/21/2017 P160012
Physio-Control, Inc. LIFEPAK EXPRESS Defibrillator 12/21/2017 P160012
Physio-Control, Inc. LIFEPAK CR2 Defibrillator 12/21/2018 P170018
Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillator 07/02/2018 P160026
Physio-Control, Inc. LIFEPAK 20E Defibrillator/ Monitor 07/02/2018 P160026
Physio-Control, Inc. LIFEPAK 1000 Defibrillator 07/02/2018 P160026
ZOLL Medical Corporation AED Plus and Fully Automatic AED Plus 05/26/2017 P160015
ZOLL Medical Corporation X Series Defibrillator 12/27/2017 P160022
ZOLL Medical Corporation R Series Defibrillator 12/27/2017 P160022
ZOLL Medical Corporation AED Pro Defibrillator 12/27/2017 P160022
ZOLL Medical Corporation AED 3 BLS Defibrillator 12/27/2017 P160022
ZOLL Medical Corporation Propaq MD Defibrillator 12/27/2017 P160022
ZOLL Medical Corporation AED 3 Defibrillator 02/28/2020 P160015/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 9146-ABE Cardiac Science (now Zoll) Powerheart G3 02/02/2021 P190013
AED Battery Exchange G5-ABE Cardiac Science (now Zoll) Powerheart G5 02/02/2021 P190013
AED Battery Exchange 5070-ABE Philips HeartStart Onsite/Home (HS1), FRx 02/02/2021 P190013
AED Battery Exchange FR3-ABE Philips HeartStart FR3 02/02/2021 P190013
Cardiac Science (now Zoll) Intellisense Lithium Battery (Model 9146, Model 9147-201-TSO) Cardiac Science (now Zoll) Powerheart G3, G3 Plus 12/07/2018 P160033
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - Adult (Model 9131) Cardiac Science (now Zoll) Powerheart G3, G3 Plus, G3 Pro 12/07/2018 P160033
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - Pediatric (Model 9730) Cardiac Science (now Zoll) Powerheart G3, G3 Plus, G3 Pro 12/07/2018 P160033
Cardiac Science (now Zoll) Intellisense Lithium Battery (ModelXBAED001A, XBTAED005A, XBTAED005A-TSO) Cardiac Science (now Zoll) Powerheart G5 12/07/2018 P160033
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - Adult (Model XELAED001A, XELAED001B, XELAD001C) Cardiac Science (now Zoll) Powerheart G5 12/07/2018 P160033
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - Pediatric (Model XELAD003A, XELAD003C) Cardiac Science (now Zoll) Powerheart G5 12/07/2018 P160033
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - ICPR Adult (Model XELAD002B, XELAED002C) Cardiac Science (now Zoll) Powerheart G5 12/07/2018 P160033
Cardiac Science (now Zoll) Intellisense Lithium Battery (Model 9145) Cardiac Science (now Zoll) Powerheart G3, G3 Plus, G3 Pro 12/06/2018 P160034
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - Adult (Model 9131) Cardiac Science (now Zoll) Powerheart G3, G3 Plus, G3 Pro 12/06/2018 P160034
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - Adult - Polarized (Model 9660) Cardiac Science (now Zoll) Powerheart G3 Pro 12/06/2018 P160034
Cardiac Science (now Zoll) Intellisense Defibrillation Pad - Pediatric (Model 9730) Cardiac Science (now Zoll) Powerheart G3, G3 Plus, G3 Pro 12/06/2018 P160034
Cardinal Health Kendall 20550 Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express 08/07/2020 P190007
Cardinal Health Kendall 20770 Adult Multi-Function Defibrillation Electrodes Zoll R Series, X Series, Propaq MD 08/07/2020 P190007
Cardinal Health Medi-Trace 22550A Cadence Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express 08/07/2020 P190007
Cardinal Health Medi-Trace 22550P Cadence Pediatric Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, and 20E 08/07/2020 P190007
Cardinal Health Medi-Trace 22550PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express 08/07/2020 P190007
Cardinal Health Medi-Trace 22550R Cadence Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express 08/07/2020 P190007
Cardinal Health Medi-Trace 22770P Cadence Pediatric Multi-Function Defibrillation Electrodes Zoll R Series, X Series, Propaq MD 08/07/2020 P190007
Cardinal Health Medi-Trace 22770PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect Zoll R Series, X Series, Propaq MD 08/07/2020 P190007
Cardinal Health Medi-Trace 22770R Cadence Adult Multi-Function Defibrillation Electrodes Zoll R Series, X Series, Propaq MD 08/07/2020 P190007
Cardinal Health Kendall 1010P Adult Multi-Function Defibrillation Electrodes Physio-Control LIFEPAK 20 and 20E 08/07/2020 P190007
Cardinal Health Kendall 1310P Adult Multi-Function Defibrillation Electrodes Physio-Control LIFPEAK 15, 20, 20E, 1000, CR Plus, and Express 08/07/2020 P190007
Cardinal Health Kendall 1410 Adult Multi-Function Defibrillation Electrodes Zoll R Series, X Series, Propaq MD 08/07/2020 P190007
Cardinal Health QUIK-COMBO Radiotransparent Physio-Control Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/2020 P190007
Cardinal Health QUIK-COMBO Physio-Control Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/2020 P190007
Cardinal Health QUIK-COMBO Redi-Pak Preconnect Medtronic Defibrillation Electrode Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express 08/07/2020 P190007
Cardinal Health QUIK-COMBO RTS Pediatric Defibrillation Electrode Physio-Control LIFEPAK 15, 20, and 20E 08/07/2020 P190007
Conmed Adult/Child 2001 (radiotransparent) and 2516 (radiotranslucent) Physio-Control LIFEPAK 15, 20, and 20E; Zoll R Series, X Series, Propaq MD 09/26/2021 P200004
Conmed Adult/Child Model 2502 (Sterile) Physio-Control LIFEPAK 15, 20, and 20E; Zoll R Series, X Series, Propaq MD 09/26/2021 P200004
Conmed Infant Model 2603 and Mini-Infant Model 2602 Physio-Control LIFEPAK 15, 20, and 20 E; Zoll R Series, X Series, Propaq MD 09/26/2021 P200004
Conmed PadPro Multi-Function Electrode Adaptors (ZMUF, ZMMF) Zoll R Series, X Series, Propaq MD 09/26/2021 P200004
Conmed PadPro Multi-Function Electrode Adaptors (MMUF, MMZF) Physio-Control LIFEPAK 15, 20, and 20E 09/26/2021 P200004
Defibtech DDP-100 Adult Defibrillation Pads Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/2021 P160032/S005
Defibtech DDP-200P Pediatric Defibrillation Pads Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/2021 P160032/S005
Defibtech DBP-1400 5 year non-rechargeable battery pack Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/2021 P160032/S005
Defibtech DBP-2800 7 year non-rechargeable battery pack Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120 06/10/2021 P160032/S005
Defibtech DDP-2001 Adult Defibrillation Pads Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475 06/10/2021 P160032/S005
Defibtech DDP-2002 Pediatric Defibrillation Pads Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475 06/10/2021 P160032/S005
Defibtech DBP-2003 4 year non-rechargeable battery pack Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475 06/10/2021 P160032/S005
Defibtech DBP-2013 4 year non-rechargeable TSO battery pack Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475 06/10/2021 P160032/S005
HeartSine Pad-Pak-01 (Adult) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/2017 P160008
HeartSine Pad-Pak-02 (Pediatric) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/2017 P160008
HeartSine Pad-Pak-7 (Aviation/TSO) HeartSine samaritan PAD 350P, 360P, and 450P 01/12/2017 P160008
Philips Primary Battery (Model M5070A) Philips HeartStart Onsite/Home (HS1), FRx 06/06/2019 P160029
Philips SMART Pads Cartridges (Adult Model M5071A) Philips HeartStart Onsite/Home (HS1) 06/06/2019 P160029
Philips SMART Pads Cartridges (Pediatric Model M5072A) Philips HeartStart Onsite/Home (HS1) 06/06/2019 P160029
Philips Primary Battery (Models 989803150161, 989803150171) Philips HeartStart FR3 05/11/2020 P160028
Philips Rechargeable Battery (Model 989803150241) Philips HeartStart FR3 05/11/2020 P160028
Philips Charger for the Rechargeable Battery (Model 861394) Philips HeartStart FR3 05/11/2020 P160028
Philips SmartPads III (Models 989803149981, 989803149991) Philips HeartStart FR3 05/11/2020 P160028
Philips Pediatric Key (Model 989803150031) Philips HeartStart FR3 05/11/2020 P160028
Philips Primary Battery (M5070A) Philips HeartStart Onsite/Home (HS1), FRx 05/11/2020 P180028
Philips Aviation FRx Battery (989803139301) Philips HeartStart FRx 05/11/2020 P180028
Philips SMART Pads II (989803139261) Philips HeartStart FRx 05/11/2020 P180028
Philips Infant/Child Key (989803139311) Philips HeartStart FRx 05/11/2020 P180028
Physio-Control CHARGE-PAK Battery Charger Physio-Control LIFEPAK CR Plus and Express 12/21/2017 P160012
Physio-Control QUICK-STEP Pacing/ECG Defibrillation Electrodes Physio-Control LIFEPAK CR2 12/21/2018 P170018
Physio-Control LIFEPAK CR2 Lithium Battery Physio-Control LIFEPAK CR2 12/21/2018 P170018
Physio-Control LIFEPAK 1000 Defibrillator Lithium-Ion Rechargeable Battery Physio-Control LIFEPAK 1000 07/02/2018 P160026
Physio-Control LIFEPAK 1000 Defibrillator Non-Rechargeable Battery Physio-Control LIFEPAK 1000 07/02/2018 P160026
Physio-Control LIFEPAK Lithium-ion Rechargeable Battery Physio-Control LIFEPAK 15 07/02/2018 P160026
Physio-Control QUIK-COMBO Therapy Cable - Lifepak 20e Physio-Control LIFEPAK 20e 07/02/2018 P160026
Physio-Control QUIK-COMBO Therapy Cable - Lifepak 15 Physio-Control LIFEPAK 15 07/02/2018 P160026
Physio-Control QUIK-PAK Electrodes Physio-Control LIFEPAK CR Plus and Express 11/29/2021 P160012/S002
Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes Physio-Control LIFEPAK 1000, CR Plus, and Express 07/08/2021 P160012/S003 (bundled)
Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes Physio-Control LIFEPAK 1000, CR Plus, and Express 07/08/2021 P160026/S015 (bundled)
Zoll CPR-D-Padz Electrode Zoll AED Plus, AED 3 05/26/2017 P160015
Zoll CPR Stat-Padz Electrode Zoll AED Plus, AED 3 05/26/2017 P160015
Zoll Stat-Padz II Electrode Zoll AED Plus, AED 3 05/26/2017 P160015
Zoll Pedi-Padz II Electrode Zoll AED Plus, AED 3 05/26/2017 P160015
Zoll AED Plus Aviation Battery Assembly Zoll AED Plus 05/26/2017 P160015
Zoll Pro-Padz Radiotransparent Electrode Zoll R Series, X Series 12/27/2017 P160022
Zoll SurePower Battery Pack Zoll R Series, AED Pro 12/27/2017 P160022
Zoll SurePower II Battery Pack Zoll X Series, Propaq MD 12/27/2017 P160022
Zoll AED Pro Non-Rechargeable Lithium Battery Pack Zoll AED Pro 12/27/2017 P160022
Zoll AED 3 Battery Pack Zoll AED 3, AED 3 BLS 12/27/2017 P160022
Zoll SurePower Charger Zoll R Series, X Series, Propaq MD, AED Pro 12/27/2017 P160022
Zoll SurePower Single Bay Charger Zoll R Series, X Series, Propaq MD, AED Pro 12/27/2017 P160022
Zoll CPR Uni-Padz electrode Zoll AED 3, AED Plus 02/28/2020 P160015/S001
Zoll AED 3 Battery Pack Zoll AED 3, AED 3 BLS 02/28/2020 P160015/S001

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 2022: 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, 2022: 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, 2020: FDA revised its compliance policy regarding the deadline for filing a PMA for previously-cleared necessary AED accessories until February 3, 2022. 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, 2020: 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 2019: 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, 2020, 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, 2017: 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 2015: The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories.
  • December 2013: The FDA issued a Safety Communication alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.
  • March 2013: 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 2011: 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.
  • November 2010: The FDA released the External Defibrillator Improvement Initiative Paper to foster the development of better-performing external defibrillators and to address the current industry practices for designing and manufacturing devices and identifying, reporting, and taking action to address device complaints they receive.
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