510(k) Report

Devices descending from K920984

163 later devices reach King of Hearts Express (E.X.) Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253306BioTracker 2.0Biotracker, LLC20260—
+6K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)20260—
+6K240229Masimo W1Masimo Corporation20241—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+6K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+6K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.20231—
+6K231276SmartCardia 7L PlatformSmartcardia SA20230—
+6K220795QT ECGQT Medical, Inc.20221—
+6K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+6K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+6K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+6K210753KardiaMobile 6LAliveCor, Inc.20212—
+6K202228Omron Model BP7900 Blood Pressure Monitor + EKGOmron Healthcare, Inc.20210—
+6K193348Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.20200—
+6K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+6K181823KardiaAIAliveCor, Inc.20196—
+6K182456Study WatchVerily Life Sciences, LLC20193—
+6K181998CardioBand ECG Event RecorderSamsung Strategy and Innovation Center (Ssic)20180—
+6K173248CardioskinBioserenity Sas20180—
+6K180895AlleyeOculocare Medical AG20181—
+6K161431SimplECGNanowear, Inc.20165—
+6K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+6K133701Nuvant MCT SystemCorventis, Inc.201423—
+7K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+7K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.20250—
+7K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+7K233521QT Ecg (QTERD100)QT Medical, Inc.20230—
+7K231620Nuubo SmartSmart Solutions Technologies SL20230—
+7K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—
+7K220350KardiaMobile 6LAliveCor, Inc.20220—
+7K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+7K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+7K201985KardiaAIAliveCor, Inc.20200—
+7K201669SimpleSENSENanowear, Inc.20203—
+7K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+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—
+8K233584RhythmStar SystemRhythMedix, LLC20241—
+8K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+8K212160SimpleSENSE PlatformNanowear, Inc.20211—
+8K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+8K182532Liba3 SystemNational Cardiac, Inc.20190—
+8K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+9K250793RhythmStar System (SL)RhythMedix, LLC20260—
+9K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+9K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+9K230375Biomonitor IVBiotronik, Inc.20231—
+9K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+9K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+10K254255S-Patch CardioAIWellysis Corp.20260—
+10K261074Biomonitor IV (471155)Biotronik, Inc.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—
+12K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+12K253141DeepRhythmAIMedicalgorithmics S.A.20250—