Data / Medical devices / United States / iRhythm Technologies, Inc.
iRhythm Technologies, Inc.: FDA-registered device maker in Cypress, CA, United States, 6 510(k) clearances
iRhythm Technologies, Inc. is registered with the FDA (registration 3021769057) in Cypress, CA, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 15, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021769057
- Address
- 6550 Katella Avenue, Cypress, CA, United States, 90630
- Owner or operator
- iRhythm Technologies, Inc. (10026250)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 26, 2012
- Registered through
- 2026
- Brand names listed
- Razor, Tape Remover Pad, ZEUS System, Zio AT device, Zio Monitor, Zio monitor device, Zio® AT Gateway, Zio® AT Patch and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Degreaser, Skin, Surgical | KOY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Manufacturer | accessdata.fda.gov |
| Razor, Surgical | LWK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | 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 |
| May 21, 2021 | K202359 | Zio Monitor | DSH | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 28, 2022 | 90954 | Class II | Ongoing | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached for either type, any further transmissions for that type will cease. Risk of delay | accessdata.fda.gov |
Compare with other makers
- All makers of Degreaser, Skin, Surgical
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Outpatient Cardiac Telemetry
- All makers of Recorder, Magnetic Tape, Medical
- All makers of Detector And Alarm, Arrhythmia
- All makers of Computer, Diagnostic, Programmable
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.