Company · US
iRhythm Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2026 | K252859 | ZEUS Platform (FG0501US) iRhythm Technologies, Inc. | DQK |
| Aug 15, 2025 | K243650 | Zio® monitor (DFG0001) iRhythm Technologies, Inc. | DSH |
| Oct 30, 2024 | K240177 | Zio AT® device (A100A1001) iRhythm Technologies, Inc. | DSI |
| Oct 21, 2024 | K240029 | Zio AT® device (A100A1001) iRhythm Technologies, Inc. | QYX |
| Feb 15, 2023 | K222389 | ZEUS System iRhythm Technologies, Inc. | DQK |
| Jul 19, 2022 | K213409 | ZEUS System (Zio Watch) iRhythm Technologies, Inc. | DQK |
| May 21, 2021 | K202527 | Zio ECG Utilization Software (ZEUS) System iRhythm Technologies, Inc. | DQK |
| May 21, 2021 | K202359 | Zio Monitor iRhythm Technologies, Inc. | DSH |
| Aug 23, 2019 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System iRhythm Technologies, Inc. | DQK |
| Aug 29, 2018 | K181502 | Zio AT ECG Monitoring System, ZEUS System iRhythm Technologies, Inc. | DQK |
| Jun 2, 2017 | K163512 | Zio AT ECG Monitoring System iRhythm Technologies, Inc. | QYX |
| Jun 19, 2015 | K143513 | ZIO SR ECG Monitoring Service iRhythm Technologies, Inc. | DSH |
| Nov 21, 2014 | K142681 | ZEUS (ZIO ECG Utilization Service) System iRhythm Technologies, Inc. | DQK |
| Jul 18, 2012 | K121319 | ZIO PATCH iRhythm Technologies, Inc. | DSH |
| Feb 6, 2012 | K113862 | ZIO PATCH iRhythm Technologies, Inc. | DSH |
| Jul 21, 2009 | K091075 | ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM iRhythm Technologies, Inc. | DQK |
| May 8, 2009 | K090363 | ZIO PATCH, MODEL Z100 iRhythm Technologies, Inc. | DSH |
| Jun 24, 2008 | K081471 | ECARD AND CCARD iRhythm Technologies, Inc. | DXH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2022 | iRhythm Technologies, Inc. Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system Open, Classified |
DSI | K163512 |