Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list iRhythm Technologies with 18 510(k) clearances, 6 AI-enabled devices, 1 device recall and 1 warning letter. The most recent is a 510(k) clearance dated May 29, 2026: ZEUS Platform (FG0501US).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 29, 2026 | ZEUS Platform (FG0501US)K252859 · DQK | 510(k) clearances |
| May 29, 2026 | ZEUS Platform (FG0501US)K252859 · Cardiovascular | AI-enabled devices |
| Aug 15, 2025 | Zio® monitor (DFG0001)K243650 · DSH | 510(k) clearances |
| Oct 30, 2024 | Zio AT® device (A100A1001)K240177 · DSI | 510(k) clearances |
| Oct 21, 2024 | Zio AT® device (A100A1001)K240029 · QYX | 510(k) clearances |
| May 25, 2023 | Warning letter: CAPA, Complaint handling, 510(k) requiredCDRH | Warning letters |
| Feb 15, 2023 | ZEUS SystemK222389 · DQK | 510(k) clearances |
| Feb 15, 2023 | ZEUS SystemK222389 · Cardiovascular | AI-enabled devices |
| Sep 28, 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitorinClass II · Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patien | Device recalls |
| Jul 19, 2022 | ZEUS System (Zio Watch)K213409 · DQK | 510(k) clearances |
| Jul 19, 2022 | ZEUS System (Zio Watch)K213409 · Cardiovascular | AI-enabled devices |
| May 21, 2021 | Zio MonitorK202359 · DSH | 510(k) clearances |
| May 21, 2021 | Zio ECG Utilization Software (ZEUS) SystemK202527 · DQK | 510(k) clearances |
| May 21, 2021 | Zio ECG Utilization Software (ZEUS) SystemK202527 · Cardiovascular | AI-enabled devices |
| Aug 23, 2019 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemK190593 · Cardiovascular | AI-enabled devices |
| Aug 29, 2018 | Zio AT ECG Monitoring System, ZEUS SystemK181502 · Cardiovascular | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
