510(k) Report

Devices descending from K994331

90 later devices reach Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient ActivatorSt Jude Medical2008581
+1K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730—
+1K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740—
+1K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc.20073—
+2K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.202093
+2K143503BioMonitorBiotronik, Inc.20159—
+2K132960BiomonitorBiotronik, Inc.201410—
+2K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143—
+2K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014231
+2K122161SJM ConfirmSt Jude Medical20124—
+2K122090SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi20124—
+2K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126—
+2K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940—
+2K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma20091—
+2K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828—
+2K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical20072—
+3K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.202241
+3K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.20211—
+3K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.202111
+3K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203—
+3K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.201724
+3K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20168—
+3K150614Reveal LINQMedtronic, Inc.201515—
+3K150117Medtronic Patient AsistantMedtronic, Inc.20151—
+3K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+3K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+3K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+3K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical20090—
+4K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.202331
+4K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+4K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.202301
+4K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm…Medtronic, Inc.20230—
+4K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+4K190574Patient Assistant Model PA97000Medtronic, Inc.20190—
+4K190548BIOMONITOR III, Remote Assistant IIIBiotronik, Inc.20195—
+4K182981Confirm Rx Insertable Cardiac MonitorAbbott20190—
+4K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+4K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical20170—
+4K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc.20170—
+4K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc.20170—
+4K160809Reveal LINQMedtronic, Inc.201612—
+4K160689Reveal LINQMedtronic, Inc.20161—
+4K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+4K142087Cova Monitoring SystemTosense, Inc.20151—
+4K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+4K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+5K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—
+5K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+5K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+5K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+5K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+5K160899CoVa Monitoring System 2Tosense, Inc.20170—
+5K162855Reveal LINQMedtronic, Inc.2017111
+5K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+5K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+5K131000V-Patch SystemIntelesens Limited20140—
+5K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+5K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+6K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+6K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+6K231276SmartCardia 7L PlatformSmartcardia SA20230—
+6K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+6K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+6K133701Nuvant MCT SystemCorventis, Inc.201423—
+7K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+7K231620Nuubo SmartSmart Solutions Technologies SL20230—
+7K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+7K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+7K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+8K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+8K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+8K233584RhythmStar SystemRhythMedix, LLC20241—
+8K230375Biomonitor IVBiotronik, Inc.20231—
+8K182532Liba3 SystemNational Cardiac, Inc.20190—
+8K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+9K261074Biomonitor IV (471155)Biotronik, Inc.20260—
+9K250793RhythmStar System (SL)RhythMedix, LLC20260—
+9K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+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—