510(k) Report

Devices descending from K960499

65 later devices reach Heartrak XL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033451Heartrak Smart at/Heartrak SMART2Universal Medical, Inc.200463—
+1K973267TTM5000 Telephonic Ekg MonitorHds Medical, Inc.19980—
+2K071130Heartrak AFUniversal Medical, Inc.200861—
+2K070014Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc.20070—
+3K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20135—
+3K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20127—
+3K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+3K083535Heartrak Smart EcatUniversal Medical, Inc.200817—
+4K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A.20180—
+4K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—
+4K152550Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A.20153—
+4K141813Rhythmstar SystemRhythMedix, LLC20148—
+4K131699Emotion Ecg MobileMega Electronics, Ltd.201316—
+4K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+4K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+4K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+5K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.20200—
+5K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+5K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+5K172311BioFlux DeviceBiotricity, Inc.20171—
+5K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+5K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+5K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+5K142087Cova Monitoring SystemTosense, Inc.20151—
+5K143032eMotion Faros ECG MobileMega Electronics, Ltd.20156—
+5K131000V-Patch SystemIntelesens Limited20140—
+5K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+5K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+6K250793RhythmStar System (SL)RhythMedix, LLC20260—
+6K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+6K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+6K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+6K231276SmartCardia 7L PlatformSmartcardia SA20230—
+6K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+6K160899CoVa Monitoring System 2Tosense, Inc.20170—
+6K161431SimplECGNanowear, Inc.20165—
+6K133701Nuvant MCT SystemCorventis, Inc.201423—
+7K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+7K231620Nuubo SmartSmart Solutions Technologies SL20230—
+7K201669SimpleSENSENanowear, Inc.20203—
+7K173248CardioskinBioserenity Sas20180—
+7K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+7K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+8K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+8K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+8K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+8K212160SimpleSENSE PlatformNanowear, Inc.20211—
+8K182532Liba3 SystemNational Cardiac, Inc.20190—
+8K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+9K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+9K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+9K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+9K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+10K254255S-Patch CardioAIWellysis Corp.20260—
+10K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+10K233755HeartKey® RhythmB-Secur Limited20240—
+10K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+11K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+11K242129VitalRhythmVitalconnect, Inc.20250—
+11K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+11K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+12K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+12K253141DeepRhythmAIMedicalgorithmics S.A.20250—