iRhythm Technologies, Inc.: FDA clearances and approvals
iRhythm Technologies, Inc. has 18 FDA 510(k) clearances (first 2008, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time: 180 days. Since 2017 its median was 262 days, against 148 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named iRhythm Technologies, Inc. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 58 |
| 2013 | 0 | — |
| 2014 | 1 | 63 |
| 2015 | 1 | 190 |
| 2016 | 0 | — |
| 2017 | 1 | 169 |
| 2018 | 1 | 83 |
| 2019 | 1 | 169 |
| 2020 | 0 | — |
| 2021 | 2 | 268 |
| 2022 | 1 | 273 |
| 2023 | 1 | 191 |
| 2024 | 2 | 286 |
| 2025 | 1 | 262 |
| 2026 | 1 | 262 |
Review time against the same product codes
Since 2017, iRhythm Technologies, Inc.'s cleared 510(k)s took a median 262 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 8 | 8 |
| DSH | Recorder, Magnetic Tape, Medical | 6 | 6 |
| QYX | Outpatient Cardiac Telemetry | 2 | 2 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (18)
Most recent iRhythm Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252859 | ZEUS Platform (FG0501US) | DQK | 2026-05-29 | 262 |
| K243650 | Zio® monitor (DFG0001) | DSH | 2025-08-15 | 262 |
| K240177 | Zio AT® device (A100A1001) | DSI | 2024-10-30 | 281 |
| K240029 | Zio AT® device (A100A1001) | QYX | 2024-10-21 | 291 |
| K222389 | ZEUS System | DQK | 2023-02-15 | 191 |
| K213409 | ZEUS System (Zio Watch) | DQK | 2022-07-19 | 273 |
| K202527 | Zio ECG Utilization Software (ZEUS) System | DQK | 2021-05-21 | 262 |
| K202359 | Zio Monitor | DSH | 2021-05-21 | 275 |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | DQK | 2019-08-23 | 169 |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | DQK | 2018-08-29 | 83 |
8 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-09-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
iRhythm Technologies, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07118124: Pediatric Adhesion and New Dermal Approach Study (Completed, started 2025-08-15)
- NCT07205367: Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II (Active not recruiting, started 2025-01-06)
- NCT04056715: Extended ECG Monitoring in HCM Patients (Completed, started 2020-01-14)
Frequently asked questions
How many FDA 510(k) clearances does iRhythm Technologies, Inc. have?
iRhythm Technologies, Inc. has 18 FDA 510(k) clearances (first 2008, latest 2026), across 5 product codes in 1 review panel.
How long does FDA take to clear iRhythm Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across iRhythm Technologies, Inc.'s cleared 510(k)s is 180 days. Since 2017: 262 days, versus 148 days for all cleared 510(k)s in the same product codes.
What devices does iRhythm Technologies, Inc. make?
Its most frequent FDA product codes are DQK (Computer, Diagnostic, Programmable, 8); DSH (Recorder, Magnetic Tape, Medical, 6); QYX (Outpatient Cardiac Telemetry, 2).
Has iRhythm Technologies, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches iRhythm Technologies, Inc; the most recent began 2022-09-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 18 iRhythm Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQK, iRhythm Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.