510(k) Report

Devices descending from K010945

183 later devices reach Heartcard, Model 5258 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K101639CG-6108 Act-IL Continuous Ecg Monitor and Arrythmia DetectorCard Guard Scientific Survival, Ltd.201022
+5K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O.20097—
+5K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd.2008182
+6K250793RhythmStar System (SL)RhythMedix, LLC20260—
+6K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+6K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+6K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+6K220350KardiaMobile 6LAliveCor, Inc.20220—
+6K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+6K201985KardiaAIAliveCor, Inc.20200—
+6K201299HD StethHd Medical, Inc.20200—
+6K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+6K181988eMurmur IDCsd Labs GmbH20197—
+6K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+6K180157QT ECGQT Medical, Inc.20182—
+6K172311BioFlux DeviceBiotricity, Inc.20171—
+6K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+6K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+6K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20160—
+6K151027zensor systemIntelesens Limited20150—
+6K143032eMotion Faros ECG MobileMega Electronics, Ltd.20156—
+6K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+6K142352CardiacLinxRoss Medical Technology, Inc.20150—
+6K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+6K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+6K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+6K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+6K111745King of Hearts Express AF Cardiac Event RecorderCard Guard Scientific Survival, Ltd.20110—
+6K101703Modification to: CG-6108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector, Model…Card Guard Scientific Survival, Ltd.20103—
+6K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+6K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.20107—
+7K254255S-Patch CardioAIWellysis Corp.20260—
+7K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+7K233755HeartKey® RhythmB-Secur Limited20240—
+7K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+7K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+7K230823AusculThing ACCAusculthing OY20230—
+7K220795QT ECGQT Medical, Inc.20221—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K220766eMurmur Heart AICsd Labs GmbH20221—
+7K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+7K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+7K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+7K173248CardioskinBioserenity Sas20180—
+7K180895AlleyeOculocare Medical AG20181—
+7K161431SimplECGNanowear, Inc.20165—
+7K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC20161—
+7K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+7K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+7K151787Holter SystemEdan Instruments, Inc.20162—
+7K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.20153—
+7K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+7K131000V-Patch SystemIntelesens Limited20140—
+7K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+7K110499CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd.201122
+8K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+8K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+8K252284eMurmur Heart AICsd Labs20250—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+8K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+8K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—
+8K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+8K242129VitalRhythmVitalconnect, Inc.20250—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+8K233521QT Ecg (QTERD100)QT Medical, Inc.20230—
+8K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+8K231276SmartCardia 7L PlatformSmartcardia SA20230—
+8K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+8K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—
+8K201669SimpleSENSENanowear, Inc.20203—
+8K183052ID-Cap SystemEtectrx, Inc.20190—
+8K152491MoMe Software PlatformInfobionic, Inc.20150—
+8K143359CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd.20151—
+9K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+9K253141DeepRhythmAIMedicalgorithmics S.A.20250—
+9K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—
+9K212160SimpleSENSE PlatformNanowear, Inc.20211—
+9K170565LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc.20170—
+10K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—