iRhythm Technologies, Inc.
Medical device manufacturer in San Francisco, CA.
18510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | 05/29/2026SE |
| K243650 | Zio® monitor (DFG0001)DSH · Traditional | 08/15/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | 10/30/2024SE |
| K240029 | Zio AT® device (A100A1001)QYX · Traditional | 10/21/2024SE |
| K222389 | ZEUS SystemDQK · Traditional | 02/15/2023SE |
| K213409 | ZEUS System (Zio Watch)DQK · Traditional | 07/19/2022SE |
| K202527 | Zio ECG Utilization Software (ZEUS) SystemDQK · Traditional | 05/21/2021SE |
| K202359 | Zio MonitorDSH · Traditional | 05/21/2021SE |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemDQK · Traditional | 08/23/2019SE |
| K181502 | Zio AT ECG Monitoring System, ZEUS SystemDQK · Traditional | 08/29/2018SE |
| K163512 | Zio AT ECG Monitoring SystemQYX · Traditional | 06/02/2017SE |
| K143513 | ZIO SR ECG Monitoring ServiceDSH · Traditional | 06/19/2015SE |
| K142681 | ZEUS (ZIO ECG Utilization Service) SystemDQK · Special | 11/21/2014SE |
| K121319 | Zio PatchDSH · Traditional | 07/18/2012SE |
| K113862 | Zio PatchDSH · Special | 02/06/2012SE |
| K091075 | Zeus (Zio ECG Utilization Service) SystemDQK · Traditional | 07/21/2009SE |
| K090363 | Zio Patch, Model Z100DSH · Traditional | 05/08/2009SE |
| K081471 | Ecard and CcardDXH · Traditional | 06/24/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0183-2023 Class II | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information…Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed… | 09/28/2022Open, Classified |