iRhythm Technologies, Inc.
iRhythm Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2026, with 1 FDA device recall on record.
Top product codes for iRhythm Technologies, Inc.
FDA recalls by iRhythm Technologies, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by iRhythm Technologies, Inc.
- K252859 — ZEUS Platform (FG0501US)
- K243650 — Zio® monitor (DFG0001)
- K240177 — Zio AT® device (A100A1001)
- K240029 — Zio AT® device (A100A1001)
- K222389 — ZEUS System
- K213409 — ZEUS System (Zio Watch)
- K202359 — Zio Monitor
- K202527 — Zio ECG Utilization Software (ZEUS) System
- K190593 — Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
- K181502 — Zio AT ECG Monitoring System, ZEUS System
- K163512 — Zio AT ECG Monitoring System
- K143513 — ZIO SR ECG Monitoring Service
- K142681 — ZEUS (ZIO ECG Utilization Service) System
- K121319 — ZIO PATCH
- K113862 — ZIO PATCH
- K091075 — ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
- K090363 — ZIO PATCH, MODEL Z100
- K081471 — ECARD AND CCARD
Data sourced from openFDA. This site is unofficial and independent of the FDA.