iRhythm Technologies, Inc.
San Francisco, CA, US
IRHYTHM TECHNOLOGIES, INC. appears in FDA device records in San Francisco, CA. FDA records list 18 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for iRhythm Technologies, Inc. between 2008 and 2026. The busiest year on record is 2009, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 2 |
| 2012 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252859 | ZEUS Platform (FG0501US) | DQK | Substantially Equivalent | |
| K243650 | Zio® monitor (DFG0001) | DSH | Substantially Equivalent | |
| K240177 | Zio AT® device (A100A1001) | DSI | Substantially Equivalent | |
| K240029 | Zio AT® device (A100A1001) | QYX | Substantially Equivalent | |
| K222389 | ZEUS System | DQK | Substantially Equivalent | |
| K213409 | ZEUS System (Zio Watch) | DQK | Substantially Equivalent | |
| K202527 | Zio ECG Utilization Software (ZEUS) System | DQK | Substantially Equivalent | |
| K202359 | Zio Monitor | DSH | Substantially Equivalent | |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | DQK | Substantially Equivalent | |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | DQK | Substantially Equivalent | |
| K163512 | Zio AT ECG Monitoring System | QYX | Substantially Equivalent | |
| K143513 | ZIO SR ECG Monitoring Service | DSH | Substantially Equivalent | |
| K142681 | ZEUS (ZIO ECG Utilization Service) System | DQK | Substantially Equivalent | |
| K121319 | ZIO PATCH | DSH | Substantially Equivalent | |
| K113862 | ZIO PATCH | DSH | Substantially Equivalent | |
| K091075 | ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM | DQK | Substantially Equivalent | |
| K090363 | ZIO PATCH, MODEL Z100 | DSH | Substantially Equivalent | |
| K081471 | ECARD AND CCARD | DXH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007208829 | 3007208829 | IRHYTHM TECHNOLOGIES, INC. | 699 8th Street, San Francisco, CA 94103 US | 2026 | |
| 3021769057 | 3021769057 | iRhythm Technologies, Inc. | 6550 Katella Avenue, Cypress, CA 90630 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0183-2023 | 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 delayed reporting to health providers. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain