Data / Medical devices / United States / Irhythm Technologies, Inc.
Irhythm Technologies, Inc.: FDA-registered device maker in San Francisco, CA, United States, 11 510(k) clearances
Irhythm Technologies, Inc. is registered with the FDA (registration 3007208829) in San Francisco, CA, United States. It lists 5 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007208829
- Address
- 699 8th Street Suite 600, San Francisco, CA, United States, 94103
- Owner or operator
- iRhythm Technologies, Inc. (10026250)
- Roles
- Specification developer
- First device listed
- December 26, 2012
- Registered through
- 2026
- Brand names listed
- ZEUS Athena System, ZEUS System, Zio AT device, Zio ECG Utilization Service (ZEUS) System, Zio ECG Utilization Software (ZEUS) System, Zio Monitor, Zio monitor device, Zio® AT Gateway and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Specification developer | accessdata.fda.gov |
| Detector And Alarm, Arrhythmia | DSI | 2 | Specification developer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Specification developer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 15, 2025 | K243650 | Zio® monitor (DFG0001) | DSH | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| October 30, 2024 | K240177 | Zio AT® device (A100A1001) | DSI | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| October 21, 2024 | K240029 | Zio AT® device (A100A1001) | QYX | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| February 15, 2023 | K222389 | ZEUS System | DQK | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| July 19, 2022 | K213409 | ZEUS System (Zio Watch) | DQK | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| May 21, 2021 | K202527 | Zio ECG Utilization Software (ZEUS) System | DQK | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| May 21, 2021 | K202359 | Zio Monitor | DSH | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| August 23, 2019 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | DQK | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| August 29, 2018 | K181502 | Zio AT ECG Monitoring System, ZEUS System | DQK | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| June 2, 2017 | K163512 | Zio AT ECG Monitoring System | QYX | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
| July 18, 2012 | K121319 | ZIO PATCH | DSH | Substantially Equivalent | iRhythm Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Recorder, Magnetic Tape, Medical
- All makers of Outpatient Cardiac Telemetry
- All makers of Detector And Alarm, Arrhythmia
Updated August 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.