510(k) Report

Devices descending from K003819

93 later devices reach Heartstream Attenuated Defibrillation Pads, Model M3870A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120536Heart Sync Pediatric Physio Aed PadHeart Sync, Inc.20120—
+1K111693Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201121
+1K033896Defibtech Aed with Attenuated Defibrillation/Monitoring Pads, Models Ddu-100 with DDP-200PDefibtech, LLC200451
+1K022929Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model…Cardiac Science, Inc.200310—
+1K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp.200275Class I
+2K122758Powerheart G5 AedCardiac Science Corporation20141—
+2K130684Philips Heartstart FR3 Automated External DefibrillatorPhilips Medical Systems201301
+2K113787Ddu-120 Fully Automatic External Defibrillator and AccessoriesDefibtech, LLC20130—
+2K120350Extended Life BatteryAed Battery Exchange, LLC20120—
+2K081259Ddu-2300 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20093—
+2K072430Zoll Pedipadz Reduced Energy ElectrodeZOLL Medical Corporation200701
+2K040479Pediatric Energy Reducer, Models Aed-10 and Aed-20Welch Allyn, Inc.20040—
+2K040438Powerheart Aed G3ACardiac Science, Inc.2004625
+2K033474Zoll Aed PlusZoll Medical Corp2004721
+2K031987Powerheart Aed G3, Model 9300Cardiac Science2003833
+3K143714Powerheart G5 AEDCardiac Science Corporation20150—
+3K141231ZP9141, ZP9146Y, ZP9146W Non-Rechargeable BatteryZeller Power Products (Battery Beast, LLC)20140—
+3K131525Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20140—
+3K121853Ddu-2400/2450 Semiautomatic External Defibrillator and AccessoriesDefibtech, LLC20120—
+3K102496Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro…Cardiac Science Corporation201122
+3K110978Onestep Pediatric Mfe'sZOLL Medical Corporation20117—
+3K110154Zoll Aed Plus with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters20112—
+3K091561Zoll Aed Plus Version 5.32 Software ReleaseZOLL Medical Corporation20100—
+3K082861Amco Replacement Battery for Powerheart Aed, Non-Rechargeable, Model 2L561; G3…Amco International Manufacturing & Design, Inc.20080—
+3K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+3K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation200523—
+3K040637Powerheart Aed G3 ProCardiac Science, Inc.200438
+4K120406Zoll Fully Automatic Aed PlusZoll Medical Corporation, World Wide Headquarters20121—
+4K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+4K110526Zoll Aedpro with 2010 Aha Guidelines Software UpdateZOLL Medical Corporation20110—
+4K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+4K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+4K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+4K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+4K090801Electronic House CallExpress MD Solutions, LLC20093—
+4K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+4K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+4K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+4K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+5K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+5K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+5K140502Zoll E Series AlsZOLL Medical Corporation20141—
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+5K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+5K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+5K102063Health-E-Connect SystemAlr Technologies20111—
+5K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+5K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+5K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+5K093895Ally Platform SystemContinuity Health Solutions20100—
+5K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+5K081574Zoll R SeriesZOLL Medical Corporation20088—
+6K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+6K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+6K163664Health-e-Connect System with IDAAlr Technologies20170—
+6K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+6K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+6K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+6K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+6K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+7K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+7K191882Masimo Centroid SystemMasimo Corporation20203—
+7K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+7K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+8K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+8K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+8K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+8K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+8K240251ANNE ChestSibel Health, Inc.20240—
+8K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+8K223498Radius VSM and AccessoriesMasimo Corporation202312
+8K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+8K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+8K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+8K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K231531Pediarity™Hinlab, Inc.20230—
+9K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—