510(k) Report

Devices descending from K013425

40 later devices reach Heartstream/Heartstart FR2 Aed Ecg Cable, Models M3860A, M3861A, M3840A, M3841A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201301
+1K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20120—
+1K120350Extended Life BatteryAed Battery Exchange, LLC20120—
+1K073716Life+Cel or Lifecel BatteryAmco International Manufacturing & Design, Inc.20080—
+1K062970I-PADCu Medical Systems, Inc.20080—
+1K052057Lifepak 500 Automated External DefibrillatorMedtronic Emergency Response Systems, Inc.200643
+1K042404Lifepak, Model 1000Medtronic Emergency Response Systems, Inc.200512
+1K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation200523—
+1K040637Powerheart Aed G3 ProCardiac Science, Inc.200438
+2K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc.20120Class I
+2K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation201122
+2K110526Zoll Aedpro with 2010 Aha Guidelines Software UpdateZOLL Medical Corporation20110—
+2K072596Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc.20080—
+2K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251…Heartsine Technologies, Inc.20062Class I
+2K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+3K122758Powerheart G5 AedCardiac Science Corporation20141—
+3K123881Heartsine Samaritan Pad 350PHeartsine Technologies, Inc.201311
+3K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+3K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+3K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+3K081574Zoll R SeriesZOLL Medical Corporation20088—
+4K143714Powerheart G5 AEDCardiac Science Corporation20150—
+4K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+4K142709samaritan PAD 450PHeartsine Technologies, Inc.20150—
+4K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+4K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+4K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+4K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+5K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—