510(k) Report

Devices descending from K181502

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+1K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+2K254255S-Patch CardioAIWellysis Corp.20260—
+2K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+2K233755HeartKey® RhythmB-Secur Limited20240—
+2K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+3K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+3K242129VitalRhythmVitalconnect, Inc.20250—
+3K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+3K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+4K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+4K253141DeepRhythmAIMedicalgorithmics S.A.20250—