510(k) Report

Devices descending from K143513

30 later devices reach ZIO SR ECG Monitoring Service through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+1K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+1K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+1K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+1K202456M5 RecorderGlobal Instrumentation, LLC20200—
+1K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL20181—
+1K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc.20171—
+1K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+1K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc.20170—
+2K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+2K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+2K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+2K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+2K233584RhythmStar SystemRhythMedix, LLC20241—
+2K231620Nuubo SmartSmart Solutions Technologies SL20230—
+2K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+3K250793RhythmStar System (SL)RhythMedix, LLC20260—
+3K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+3K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+3K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+4K254255S-Patch CardioAIWellysis Corp.20260—
+4K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+4K233755HeartKey® RhythmB-Secur Limited20240—
+4K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+5K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+5K242129VitalRhythmVitalconnect, Inc.20250—
+5K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+5K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+6K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+6K253141DeepRhythmAIMedicalgorithmics S.A.20250—