510(k) Report

Devices descending from K121319

36 later devices reach Zio Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202359Zio MonitoriRhythm Technologies, Inc.20212—
+1K201644QardioCoreQardio, Inc.20211—
+1K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc.201530—
+2K250882Sansa HsatHuxley Medical20250—
+2K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.20250—
+2K240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.20240—
+2K232670HiCardi+ H100MEZOO Co., Ltd.20240—
+2K223049CardioSTAT® ECG Test SolutionIcentia, Inc.20230—
+2K203638AT-Patch ECG Analysis SystemAtsens Co., Ltd.20221—
+2K210179QOCA Portable ECG Monitoring DeviceQuanta Computer, Inc.20220—
+2K202456M5 RecorderGlobal Instrumentation, LLC20200—
+2K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL20181—
+2K171936Peerbridge Cor (TM) SystemPeerbridge Health, Inc.20171—
+2K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.2017181
+2K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc.20170—
+3K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.20260—
+3K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+3K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.20250—
+3K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+3K233584RhythmStar SystemRhythMedix, LLC20241—
+3K231620Nuubo SmartSmart Solutions Technologies SL20230—
+3K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+4K250793RhythmStar System (SL)RhythMedix, LLC20260—
+4K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+4K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+4K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+5K254255S-Patch CardioAIWellysis Corp.20260—
+5K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+5K233755HeartKey® RhythmB-Secur Limited20240—
+5K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+6K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+6K242129VitalRhythmVitalconnect, Inc.20250—
+6K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+6K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+7K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+7K253141DeepRhythmAIMedicalgorithmics S.A.20250—