510(k) Report

Devices descending from K081365

58 later devices reach SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143503BioMonitorBiotronik, Inc.20159—
+1K132960BiomonitorBiotronik, Inc.201410—
+1K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+1K122161SJM ConfirmSt Jude Medical20124—
+1K122090SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi20124—
+1K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940—
+2K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+2K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+2K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+2K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+2K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+3K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+3K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+3K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+3K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+3K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+3K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+3K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+3K142087Cova Monitoring SystemTosense, Inc.20151—
+3K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+3K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+4K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+4K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+4K160899CoVa Monitoring System 2Tosense, Inc.20170—
+4K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+4K131000V-Patch SystemIntelesens Limited20140—
+4K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+4K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+5K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+5K231276SmartCardia 7L PlatformSmartcardia SA20230—
+5K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+5K133701Nuvant MCT SystemCorventis, Inc.201423—
+6K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+6K231620Nuubo SmartSmart Solutions Technologies SL20230—
+6K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+6K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+6K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+7K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+7K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+7K233584RhythmStar SystemRhythMedix, LLC20241—
+7K230375Biomonitor IVBiotronik, Inc.20231—
+7K182532Liba3 SystemNational Cardiac, Inc.20190—
+7K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+8K261074Biomonitor IV (471155)Biotronik, Inc.20260—
+8K250793RhythmStar System (SL)RhythMedix, LLC20260—
+8K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+8K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+8K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+9K254255S-Patch CardioAIWellysis Corp.20260—
+9K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+9K233755HeartKey® RhythmB-Secur Limited20240—
+9K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+10K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+10K242129VitalRhythmVitalconnect, Inc.20250—
+10K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+10K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+11K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+11K253141DeepRhythmAIMedicalgorithmics S.A.20250—