Atlas FDA

MKJ

228 FDA 510(k) clearances · Product code

132 daysmedian time to decision
322 days90th percentile
228clearances measured

FDA profile

Official device name
Automated External Defibrillators (Non-Wearable)
Device class
Class III (high risk)
Regulation
21 CFR 870.5310
Medical specialty
Cardiovascular
FDA definition
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.
Adverse events (MAUDE)
2021: 16,300 · 2022: 14,867 · 2023: 13,766 · 2024: 15,113 · 2025: 13,472 · 2026: 6,896
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Powerheart G5 AED (K143714)Cardiac Science Corporation2015-05-04
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (K150198)Bio-Detek, Inc.2015-05-02
OneStep Pediatric CPR Multi-Function Electrode (K150055)Bio-Detek, Inc.2015-05-02
samaritan PAD 450P (K142709)Heartsine Technologies, Inc.2015-03-27
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING (K133659)Philips Medical Systems2015-01-23
ZOLL E SERIES (K133239)Zoll Medical Corporation, World Wide Headquarters2015-01-16
LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 (K141795)R & D Batteries, Inc.2014-12-08
ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
Skintact, various other tradenames (K142803)Leonhard Lang GmbH2014-12-02
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231)Zeller Power Products (Battery Beast, LLC)2014-11-25
ZOLL X SERIES (K141774)ZOLL Medical Corporation2014-11-19
ONESTEP CPR II MULTI-FUNCTION ELECTRODE (K133441)Bio-Detek, Inc.2014-10-10
ZOLL X SERIES (K133484)Zoll Medical Corp2014-08-01
ZOLL X SERIES (K133269)Zoll Medical Corporation, World Wide Headquarters2014-05-22
SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K131525)Defibtech, LLC2014-04-24
POWERHEART G5 AED (K122758)Cardiac Science Corporation2014-02-12
HEART SYNC (K131550)Heart Sync, Inc.2013-12-06
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K130684)Philips Medical Systems2013-10-18
HEART SYNC (K131494)Heart Sync, Inc.2013-09-16
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (K130454)Physio-Control, Inc.2013-08-21
HEARTSINE SAMARITAN PAD 350P (K123881)Heartsine Technologies, Inc.2013-07-11
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST (K130153)Philips Medical Systems2013-03-12
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K113787)Defibtech, LLC2013-01-04
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K121853)Defibtech, LLC2012-12-13
ZOLL SUREPOWER SINGLE BAY CHARGER (K122839)ZOLL Medical Corporation2012-12-13
EXTENDED LIFE BATTERY (K120350)Aed Battery Exchange, LLC2012-11-01
ZOLL FULLY AUTOMATIC AED PLUS (K120406)Zoll Medical Corporation, World Wide Headquarters2012-10-26
LIFEPAK 1000 DEFIBRILLATOR (K122600)Physio-Control, Inc.2012-10-11
ZOLL R SERIES (K120907)Zoll Medical Corporation, World Wide Headquarters2012-09-25
HEART SYNC PEDIATRIC PHYSIO AED PAD (K120536)Heart Sync, Inc.2012-08-06
ZOLL PROPAQ MD (K112761)Zoll Medical Corporation, World Wide Headquarters2012-04-25
ZOLL X SERIES (K112432)Zoll Medical Corporation, World Wide Headquarters2012-03-21
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES (K110825)Philips Medical Systems2012-02-16
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K111693)Philips Medical Systems2011-10-28
ZOLL E SERIES (K111594)Zoll Medical Corporation, World Wide Headquarters2011-08-17
POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS (K102496)Cardiac Science Corporation2011-06-09
ONESTEP PEDIATRIC MFE'S (K110978)ZOLL Medical Corporation2011-05-13
ONESTEP ADULT MULTI-FUNCTION ELECTRODE (K110742)ZOLL Medical Corporation2011-04-13
ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110526)ZOLL Medical Corporation2011-03-25
LIFEPAK 15 MONITOR/DEFIBRILLATOR (K103567)Physio-Control, Inc.2011-03-22
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE (K110361)Zoll Medical Corporation, World Wide Headquarters2011-03-08
ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110154)Zoll Medical Corporation, World Wide Headquarters2011-02-17
ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE (K110168)Zoll Medical Corporation, World Wide Headquarters2011-02-17
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES (K103186)Leonhard Lang GmbH2011-02-08
LIFEPAK 12 (K102972)Physio-Control, Inc.2010-12-22
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 (K100565)Bio-Detek, Inc.2010-11-16
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE (K091561)ZOLL Medical Corporation2010-09-23
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED (K092391)Concord Medical Products2010-04-01
ZOLL E SERIES WITH CPRREADYCHARGE (K091265)Zoll Medical Corporation, World Wide Headquarters2009-12-23
ZOLL E SERIES WITH SPCO/SPMET OPTION (K092598)Zoll Medical Corporation, World Wide Headquarters2009-12-03
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES (K090989)Zoll Medical Corp2009-09-23
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A (K091943)Cardiac Science Corporation2009-09-10
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A (K091548)Amco International Manufacturing & Design, Inc.2009-08-07
DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (K081259)Defibtech, LLC2009-06-15
LIFEPAK 15 MONITOR/DEFIBRILLATOR (K082937)Physio-Control, Inc.2009-03-11
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING (K081081)Zoll Medical Corporation, World Wide Headquarters2009-03-09
9131 DEFIBRILLATION ELECTRODES (K082090)Cardiac Science Corporation2008-12-12
ZOLL R SERIES BLS DEFIBRILLATOR (K081828)ZOLL Medical Corporation2008-12-09
ZOLL E SERIES WITH INTIBATION ASSIST OPTION (K080903)ZOLL Medical Corporation2008-12-04
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 (K082861)Amco International Manufacturing & Design, Inc.2008-11-25
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL (K081371)Leonhard Lang GmbH2008-09-24
LIFEPAK 20E (K073089)Physio-Control, Inc.2008-07-29
ZOLL E SERIES DEFIBRILLATOR (K072923)Zoll Medical Corporation, World Wide Headquarters2008-04-24
ZOLL E SERIES 12SL, ANALYSIS OPTION (K080232)Zoll Medical Corporation, World Wide Headquarters2008-04-23
LIFE+CEL OR LIFECEL BATTERY (K073716)Amco International Manufacturing & Design, Inc.2008-04-11
HEART SYNC, MODELS C-100 AND T-100 (K080421)Heart Sync, LLC2008-02-29
PHILIPS HEARTSTART SMARTPADS III (K072812)Philips Medical Systems2008-02-26
LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 (K072596)Amco International Manufacturing & Design, Inc.2008-01-24
I-PAD (K062970)Cu Medical Systems, Inc.2008-01-22
ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE (K072430)ZOLL Medical Corporation2007-11-06
SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS (K072233)Leonhard Lang GmbH2007-10-05
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO (K071025)Zoll Medical Corporation, World Wide Headquarters2007-06-22
ZOLL E SERIES WITH SEE-THRU CPR (K070455)Zoll Medical Corporation, World Wide Headquarters2007-04-26
ZOLL M SERIES WITH REAL CPR HELP (K062537)ZOLL Medical Corporation2007-02-28
LIFEPAK 12 DEFIBRILLATOR/MONITOR (K063510)Medtronic Emergency Response Systems, Inc.2007-01-26
HEARTSTART MRX, MODELS M3535A OR M3536A (K063375)Philips Medical Systems2007-01-11
LIFEPAK 20 DEFIBRILLATOR/ MONITOR (K063119)Medtronic Emergency Response Systems, Inc.2006-12-22
ZOLL E SERIES WITH REAL CPR HELP (K062177)ZOLL Medical Corporation2006-12-13
REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 (K052465)Heartsine Technologies, Inc.2006-12-12
HEARTSTART MRX MONITOR/DEFIBRILLATOR (K062233)Philips Medical Systems North America, Inc.2006-11-22
ZOLL R SERIES DEFIBRILLATOR (K060559)ZOLL Medical Corporation2006-08-17
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS (K061707)Philips Medical Systems2006-08-11
MODIFICATION TO POWERHEART ECD (K060934)Cardiac Science Corporation2006-05-15
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K052057)Medtronic Emergency Response Systems, Inc.2006-02-17
POWERHEART ECD (K052316)Cardiac Science, Inc.2006-01-03
LIFEPAK, MODEL 1000 (K042404)Medtronic Emergency Response Systems, Inc.2005-12-22
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) (K052161)Cardiac Science, Inc.2005-10-21
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A (K051632)Philips Medical Systems2005-10-05
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134)Philips Medical Systems2005-09-08
ZOLL M SERIES 12SL ANALYSIS OPTION (K051475)ZOLL Medical Corporation2005-06-24
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES (K051076)ZOLL Medical Corporation2005-05-13
ZOLL E SERIES DEFIBRILLATOR (K042007)Zoll Medical Corp2005-04-07
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 (K050004)Philips Medical Systems2005-02-25
ZOLL AED PRO EXTERNAL DEFIBRILLATOR (K041892)ZOLL Medical Corporation2005-02-04
ZOLL M SERIES ETC02 LOFLO OPTION (K042417)Zoll Medical Corp2004-10-05
PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 (K040479)Welch Allyn, Inc.2004-09-14
SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 (K041883)Leonhard Lang GmbH2004-09-07
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 (K042088)Heartsine Technologies, Inc.2004-09-02
POWERHEART AED G3 PRO (K040637)Cardiac Science, Inc.2004-08-06
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Every clearance here is in the API, with alerts when new ones post.