510(k) Report

Devices descending from K955628

48 later devices reach Fore Runner External Defibrillator/Defibrillator Pads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120350Extended Life BatteryAed Battery Exchange, LLC20120—
+1K091548Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc.20090—
+1K041883Skintact Multifunction Electrodes, Model DF 21Leonhard Lang GmbH20044—
+1K013896Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…Defibtech, LLC200265
+1K991910Lifepak 12 BiphasicPhysio-Control Corp.1999223
+1K983393Lifepak 500 BiphasicPhysio-Control Corp.1999251
+1K982264Firstsave Biphasic Models 9200 and 9210Survivalink Corp.19999—
+2K113787Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC20130—
+2K102972Lifepak 12Physio-Control, Inc.201001
+2K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20093—
+2K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.200953
+2K062970I-PADCu Medical Systems, Inc.20080—
+2K072233Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…Leonhard Lang GmbH200732
+2K062331Highpak-12Ad Elektronik GmbH20070—
+2K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.200772
+2K052057Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc.200643
+2K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc.200512
+2K040438Powerheart Aed G3ACardiac Science, Inc.2004625
+2K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc.20049—
+2K040775Lifepak 12Medtronic Physio-Control Corp.2004101
+2K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp.2003201
+2K031987Powerheart Aed G3, Model 9300Cardiac Science2003833
+2K020984Accessaed, Semi-Automatic External DefibrillatorsAccess Cardiosystems, Inc.200202
+2K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp.20022117
+2K012428Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp.2001212
+3K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.20142Class I
+3K142803Skintact, various other tradenamesLeonhard Lang GmbH20140Class I
+3K141231ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryZeller Power Products (Battery Beast, LLC)20140—
+3K131525Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20140—
+3K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc.20130Class I
+3K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20120—
+3K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc.20120Class I
+3K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation201122
+3K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc.20114—
+3K103186Skintact Radiotransparent Multifunction ElectrodesLeonhard Lang GmbH20110—
+3K082861Amco Replacement Battery for Powerheart Aed, Non-Rechargeable, Model 2L561; G3…Amco International Manufacturing & Design, Inc.20080—
+3K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH20080Class I
+3K073089Lifepak 20EPhysio-Control, Inc.200811
+3K072596Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc.20080—
+3K063119Lifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc.200625
+3K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251…Heartsine Technologies, Inc.20062Class I
+3K040637Powerheart Aed G3 ProCardiac Science, Inc.200438
+4K240162LIFEPAK® 35 AC Power Adapter (41335-000001)Stryker Physio-Control20241—
+4K122758Powerheart G5 AedCardiac Science Corporation20141—
+4K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc.201311
+5K253099LIFEPAK 15 AC Power Adapter (41577-000333)Physio-Control, Inc.20250—
+5K143714Powerheart G5 AEDCardiac Science Corporation20150—
+5K142709samaritan PAD 450PHeartsine Technologies, Inc.20150—