510(k) Report

Devices descending from K922218

77 later devices reach IQ System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042113Zoe Fluid Status MonitorNoninvasive Medical Technologies, LLC200476—
+2K150095ReDs Wearable SystemSensible Medical Innovations, Ltd.20151—
+2K142087Cova Monitoring SystemTosense, Inc.20151—
+2K112830Zoefluid Status Monitor (Model Zoe 2B)Noninvasive Medical Technologies, Inc.201219—
+2K113187Avivo Mobile Patient ManagementCorventis, Inc.20125—
+2K083287Avivo Mobile Patient Management SystemCorventis, Inc.200957—
+3K180479ReDS SystemSensible Medical Innovations, Ltd.20190—
+3K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+3K160899CoVa Monitoring System 2Tosense, Inc.20170—
+3K153160AVIVO Mobile Patient Management (MPM) SystemMedtronic, Inc.20160—
+3K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+3K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+3K133301Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc.201417—
+3K131509Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc.201318—
+3K121197Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectPreventice, Inc.201210—
+3K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc.200938—
+3K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940—
+4K250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical, Ltd.20250—
+4K211585Bodyport Cardiac ScaleBodyport, Inc.20220—
+4K193296eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc.20203—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+4K173248CardioskinBioserenity Sas20180—
+4K162956Nowcardio SystemContex International Technologies (Canada), Inc.20171—
+4K161431SimplECGNanowear, Inc.20165—
+4K142503Imed-Z Fluid Status MonitorIntersection Medical, Inc.201510—
+4K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc.20141—
+4K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.201130—
+4K102111Medical Magnetic Tape RecorderWpr Medical AS20100—
+4K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.20106—
+5K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC20250—
+5K243727Re:BalansMode Sensors AS20250—
+5K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.20250—
+5K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited20221—
+5K201669SimpleSENSENanowear, Inc.20203—
+5K182532Liba3 SystemNational Cardiac, Inc.20190—
+5K172507SOZOImpediMed Limited20177—
+5K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20163—
+5K152491MoMe Software PlatformInfobionic, Inc.20150—
+5K131000V-Patch SystemIntelesens Limited20140—
+5K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.201224—
+5K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc.20110—
+6K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.20250—
+6K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+6K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+6K231276SmartCardia 7L PlatformSmartcardia SA20230—
+6K212160SimpleSENSE PlatformNanowear, Inc.20211—
+6K193410SOZO Body Fluid AnalyzerImpediMed Limited20204—
+6K190529SOZOImpediMed Limited20191—
+6K133701Nuvant MCT SystemCorventis, Inc.201423—
+7K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K231620Nuubo SmartSmart Solutions Technologies SL20230—
+7K230531SOZO ProImpediMed Limited20230—
+7K203473SOZOImpediMed Limited20213—
+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—
+8K232089SOZO ProImpediMed Limited20232—
+8K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+9K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited20260—
+9K250793RhythmStar System (SL)RhythMedix, LLC20260—
+9K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited20260—
+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—