iRhythm Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 17
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0183-2023 | Class II | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: AL | September 28, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243650 | Zio® monitor (DFG0001) | August 15, 2025 |
| K240177 | Zio AT® device (A100A1001) | October 30, 2024 |
| K240029 | Zio AT® device (A100A1001) | October 21, 2024 |
| K222389 | ZEUS System | February 15, 2023 |
| K213409 | ZEUS System (Zio Watch) | July 19, 2022 |
| K202527 | Zio ECG Utilization Software (ZEUS) System | May 21, 2021 |
| K202359 | Zio Monitor | May 21, 2021 |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | August 23, 2019 |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | August 29, 2018 |
| K163512 | Zio AT ECG Monitoring System | June 2, 2017 |
| K143513 | ZIO SR ECG Monitoring Service | June 19, 2015 |
| K142681 | ZEUS (ZIO ECG Utilization Service) System | November 21, 2014 |
| K121319 | ZIO PATCH | July 18, 2012 |
| K113862 | ZIO PATCH | February 6, 2012 |
| K091075 | ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM | July 21, 2009 |
| K090363 | ZIO PATCH, MODEL Z100 | May 8, 2009 |
| K081471 | ECARD AND CCARD | June 24, 2008 |