510(k) Report

Devices descending from K042254

99 later devices reach PMP4 Selfcheck Ecg through their predicates, nearest generation first.

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