FDA.report

Product code MKJ

Current FDA Classification

Device name
Automated External Defibrillators (Non-Wearable)
Medical specialty
Cardiovascular
Device class
3
Regulation number
870.5310
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.

Related PMA Records

PMADeviceApplicantDecision date
P160026S011LIFEPAK 20e defibrillator/monitorPhysio-Control. Inc.2019-11-25
P160008S007HeartSine’s samaritan Public Access Automated External Defibrillators and AccessoriesHeartSine Technologies, Ltd.2019-11-19
P160026S010LIFEPAK 20e Defibrillator/MonitorPhysio-Control. Inc.2019-10-25
P170018S004LIFEPAK® CR2 DefibrillatorPhysio-Control, Inc2019-10-23
P160022S012AED ProZOLL MEDICAL CORPORATION2019-08-22
P160034S001Powerheart® G3 Pro AEDCardiac Science Corporation2019-08-20
P160033S004Powerheart® G3, G3 Plus and G5 AEDsCARDIAC SCIENCE CORPORATION2019-08-20
P160022S011Zoll R SeriesZOLL MEDICAL CORPORATION2019-08-09
P160033S002Powerheart G5 Automated External DefibrillatorCARDIAC SCIENCE CORPORATION2019-07-25
P160026S009LIFEPAK Automated External Defibrillators (AEDs)Physio-Control. Inc.2019-07-10
P160022S010X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ZOLL MEDICAL CORPORATION2019-07-03
P160008S006samaritan Public Access Automated External DefibrillatorsHeartSine Technologies LLC2019-06-19
P160026S008LIFEPAK Automated External Defibrillators (AED)Physio-Control. Inc.2019-05-17
P160026S006LIFEPAK® 20e defibrillator/monitorPhysio-Control. Inc.2019-05-09
P170018S003LIFEPAK CR2 DefibrillatorPhysio-Control, Inc2019-05-02
P160015S002CPR Stat-Padz Electrode and CPR-D Padz ElectrodeZOLL MEDICAL CORPORATION2019-03-27
P160026S004LIFEPAK 15 monitor/defibrillatorPhysio-Control. Inc.2019-03-24
P160022S009X Series/Propaq MDZOLL MEDICAL CORPORATION2019-03-21
P160008S005samaritan Public Access Automated External Defibrillators and AccessoriesHeartSine Technologies LLC2019-03-04
P170018S002LIFEPAK® CR2 DefibrillatorPhysio-Control, Inc2019-02-19
P170018S001LIFEPAK CR2 DefibrillatorPhysio-Control, Inc2019-02-19
P160008S004HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and AccessoriesHeartSine Technologies LLC2019-02-19
P160026S005LIFEPAK Automated External Defibrillators (AEDs)Physio-Control. Inc.2019-01-22
P170018LIFEPAK® CR2 DefibrillatorPhysio-Control, Inc2018-12-21
P160033S001Powerheart G5 AEDCARDIAC SCIENCE CORPORATION2018-12-20
P160008S003HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)HeartSine Technologies LLC2018-12-17
P160033Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3CARDIAC SCIENCE CORPORATION2018-12-07
P160034Powerheart® AED G3 ProCardiac Science Corporation2018-12-06
P160032S001Defibtech Automated External Defibrillator (AED) SystemsDEFIBTECH, LLC2018-12-06
P160026S003LIFEPAK 15 monitor/defibrillatorPhysio-Control. Inc.2018-12-06

Related 510(k) Records

510(k)DeviceApplicantDecision date
K143714Powerheart G5 AEDCardiac Science Corporation2015-05-04
K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.2015-05-02
K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.2015-05-02
K142709samaritan PAD 450PHeartsine Technologies, Inc.2015-03-27
K133659HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORINGPhilips Medical Systems2015-01-23
K133239ZOLL E SERIESZoll Medical Corporation, World Wide Headquarters2015-01-16
K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.2014-12-19
K141795BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500R & D Batteries, Inc.2014-12-08
K142915ZOLL X SeriesZOLL Medical Corporation2014-12-03
K142803Skintact, various other tradenamesLeonhard Lang GmbH2014-12-02
K141231ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERYZeller Power Products (Battery Beast, LLC)2014-11-25
K141774ZOLL X SERIESZOLL Medical Corporation2014-11-19
K133441ONESTEP CPR II MULTI-FUNCTION ELECTRODEBio-Detek, Inc.2014-10-10
K133484ZOLL X SERIESZoll Medical Corp2014-08-01
K133269ZOLL X SERIESZoll Medical Corporation, World Wide Headquarters2014-05-22
K131525SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC2014-04-24
K122758POWERHEART G5 AEDCardiac Science Corporation2014-02-12
K131550HEART SYNCHeart Sync, Inc.2013-12-06
K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems2013-10-18
K131494HEART SYNCHeart Sync, Inc.2013-09-16
K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.2013-08-21
K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.2013-07-11
K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems2013-03-12
K113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC2013-01-04
K122839ZOLL SUREPOWER SINGLE BAY CHARGERZOLL Medical Corporation2012-12-13
K121853DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC2012-12-13
K120350EXTENDED LIFE BATTERYAed Battery Exchange, LLC2012-11-01
K120406ZOLL FULLY AUTOMATIC AED PLUSZoll Medical Corporation, World Wide Headquarters2012-10-26
K122600LIFEPAK 1000 DEFIBRILLATORPhysio-Control, Inc.2012-10-11
K120907ZOLL R SERIESZoll Medical Corporation, World Wide Headquarters2012-09-25

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