ZEUS System (Zio Watch)
FDA 510(k) K213409 · iRhythm Technologies, Inc.
510(k) numberK213409
Submission
- Device name
- ZEUS System (Zio Watch)
- Applicant
- iRhythm Technologies, Inc.
San Francisco, CA, US - Received
- October 19, 2021
- Decision date
- July 19, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
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| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 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 |
| 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 |
Questions and answers
When was ZEUS System (Zio Watch) cleared by the FDA?
ZEUS System (Zio Watch) (K213409) received a 510(k) decision of Substantially Equivalent on July 19, 2022, 273 days after the submission was received.
What is the product code of K213409?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.