510(k) Report

Devices descending from K964836

100 later devices reach Card Guard, Model CG-7100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042254PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd.200599—
+2K133703Physioglove ET SystemCommwell R&D, Ltd.20140—
+2K122184Ecg CheckCardiac Designs, LLC201330—
+2K100383Vitaphone. Model 100 BTVitasystems GmbH20101—
+2K083174HealthepodCard Guard Scientific Survival, Ltd.200915—
+2K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd.200644—
+2K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH20062—
+2K050853PMP4 SpiroproCard Guard Scientific Survival, Ltd.20052—
+3K170506ECG Check - Universal, ECG Check - Universal PlusCardiac Designs, Inc.20170—
+3K170181PrizmaG-Medical Innovations, Ltd.20171—
+3K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH20150—
+3K140933Alivecor Heart MonitorAliveCor, Inc.2014281
+3K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+3K083535Heartrak Smart EcatUniversal Medical, Inc.200817—
+3K072722Meddorna Wireless PRN Spirometer 100Meddorna, LLC20080—
+3K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2007252
+3K060703PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd.20060—
+4K201456Scan MonitorWithings SA202161
+4K173589PrizmaG-Medical Innovations, Ltd.20180—
+4K142743AliveCor Heart MonitorAliveCor, Inc.201519—
+4K142672AliveCor Heart MonitorAliveCor, Inc.20144—
+4K141813Rhythmstar SystemRhythMedix, LLC20148—
+4K131699Emotion Ecg MobileMega Electronics, Ltd.201316—
+4K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+4K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc.20111—
+4K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+4K101639CG-6108 Act-IL Continuous Ecg Monitor and Arrythmia DetectorCard Guard Scientific Survival, Ltd.201022
+4K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O.20097—
+4K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2008182
+5K243305Masimo W1Masimo Corporation20250—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K232512Masimo W1Masimo Corporation20232—
+5K230812Withings Scan Monitor 2.0Withings20230—
+5K221260CSF-3Cardiacsense20231—
+5K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+5K183319Triangle SystemAliveCor, Inc.20193—
+5K182579Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20192—
+5K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+5K182040Coala Heart MonitorCoala Life AB20190—
+5K172311BioFlux DeviceBiotricity, Inc.20171—
+5K171816Kardia Band SystemAliveCor, Inc.201712—
+5K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+5K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+5K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20160—
+5K151027zensor systemIntelesens Limited20150—
+5K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc.20150—
+5K143032eMotion Faros ECG MobileMega Electronics, Ltd.20156—
+5K142352CardiacLinxRoss Medical Technology, Inc.20150—
+5K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+5K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+5K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+5K111745King of Hearts Express AF Cardiac Event RecorderCard Guard Scientific Survival, Ltd.20110—
+5K101703Modification to: CG-6108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector, Model…Card Guard Scientific Survival, Ltd.20103—
+5K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+5K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.20107—
+6K250793RhythmStar System (SL)RhythMedix, LLC20260—
+6K240229Masimo W1Masimo Corporation20241—
+6K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+6K210753KardiaMobile 6LAliveCor, Inc.20212—
+6K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20210—
+6K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+6K193348Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.20200—
+6K181823KardiaAIAliveCor, Inc.20196—
+6K182456Study WatchVerily Life Sciences, LLC20193—
+6K181998CardioBand ECG Event RecorderSamsung Strategy and Innovation Center (Ssic)20180—
+6K161431SimplECGNanowear, Inc.20165—
+6K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC20161—
+6K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+6K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+6K151787Holter SystemEdan Instruments, Inc.20162—
+6K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.20153—
+6K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+6K131000V-Patch SystemIntelesens Limited20140—
+6K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+6K110499CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.201122
+7K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+7K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+7K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+7K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+7K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—
+7K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+7K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+7K231276SmartCardia 7L PlatformSmartcardia SA20230—
+7K220350KardiaMobile 6LAliveCor, Inc.20220—
+7K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+7K201985KardiaAIAliveCor, Inc.20200—
+7K201669SimpleSENSENanowear, Inc.20203—
+7K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+7K183052ID-Cap SystemEtectrx, Inc.20190—
+7K173248CardioskinBioserenity Sas20180—
+7K152491MoMe Software PlatformInfobionic, Inc.20150—
+7K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20151—
+8K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+8K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+8K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+8K212160SimpleSENSE PlatformNanowear, Inc.20211—
+8K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.20170—
+9K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—