510(k) Report

Devices descending from K012241

76 later devices reach Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072558Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005Cardionet, Inc.200767—
+1K063222Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004Cardionet, Inc.200673—
+1K052240Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc.200575—
+2K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+2K124060Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20135—
+2K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.20127—
+2K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+2K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+2K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc.20107—
+2K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+2K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940—
+2K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O.20097—
+2K083287Avivo Mobile Patient Management SystemCorventis, Inc.200957—
+2K053263Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003Cardionet, Inc.20068—
+3K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics S.A.20180—
+3K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—
+3K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC20161—
+3K151787Holter SystemEdan Instruments, Inc.20162—
+3K152491MoMe Software PlatformInfobionic, Inc.20150—
+3K152550Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A.20153—
+3K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+3K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+3K121197Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectPreventice, Inc.201210—
+3K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+3K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+4K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+4K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+4K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+4K193296eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc.20203—
+4K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+4K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.20200—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K173248CardioskinBioserenity Sas20180—
+4K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+4K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+4K161431SimplECGNanowear, Inc.20165—
+4K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+4K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+4K142087Cova Monitoring SystemTosense, Inc.20151—
+4K133701Nuvant MCT SystemCorventis, Inc.201423—
+4K131000V-Patch SystemIntelesens Limited20140—
+5K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+5K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.20250—
+5K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+5K231276SmartCardia 7L PlatformSmartcardia SA20230—
+5K231620Nuubo SmartSmart Solutions Technologies SL20230—
+5K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited20221—
+5K201669SimpleSENSENanowear, Inc.20203—
+5K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+5K182532Liba3 SystemNational Cardiac, Inc.20190—
+5K160899CoVa Monitoring System 2Tosense, Inc.20170—
+5K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.20250—
+6K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+6K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+6K233584RhythmStar SystemRhythMedix, LLC20241—
+6K212160SimpleSENSE PlatformNanowear, Inc.20211—
+6K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+7K250793RhythmStar System (SL)RhythMedix, LLC20260—
+7K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+7K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+8K254255S-Patch CardioAIWellysis Corp.20260—
+8K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+8K233755HeartKey® RhythmB-Secur Limited20240—
+8K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+9K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+9K242129VitalRhythmVitalconnect, Inc.20250—
+9K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+9K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+10K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+10K253141DeepRhythmAIMedicalgorithmics S.A.20250—