510(k) Report

Devices descending from K163512

18 later devices reach Zio AT ECG Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+1K240029Zio AT® device (A100A1001)iRhythm Technologies, Inc.20241—
+1K233584RhythmStar SystemRhythMedix, LLC20241—
+1K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc.201812—
+2K250793RhythmStar System (SL)RhythMedix, LLC20260—
+2K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.20240—
+2K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+2K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+3K254255S-Patch CardioAIWellysis Corp.20260—
+3K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+3K233755HeartKey® RhythmB-Secur Limited20240—
+3K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+4K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+4K242129VitalRhythmVitalconnect, Inc.20250—
+4K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+4K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+5K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+5K253141DeepRhythmAIMedicalgorithmics S.A.20250—