Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
iRhythm Technologies, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
281 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | 2026-05-29 | 262 | 0 |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | 2025-08-15 | 262 | 0 |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-30 | 281 | 0 |
| K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-21 | 291 | 0 |
| K222389 | ZEUS System | iRhythm Technologies, Inc. | 2023-02-15 | 191 | 0 |
| K213409 | ZEUS System (Zio Watch) | iRhythm Technologies, Inc. | 2022-07-19 | 273 | 0 |
| K202527 | Zio ECG Utilization Software (ZEUS) System | iRhythm Technologies, Inc. | 2021-05-21 | 262 | 0 |
| K202359 | Zio Monitor | iRhythm Technologies, Inc. | 2021-05-21 | 275 | 0 |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2019-08-23 | 169 | 0 |
| K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018-08-29 | 83 | 0 |
| K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017-06-02 | 169 | 1 |
| K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015-06-19 | 190 | 0 |
| K142681 | ZEUS (ZIO ECG Utilization Service) System | iRhythm Technologies, Inc. | 2014-11-21 | 63 | 0 |
| K121319 | ZIO PATCH | iRhythm Technologies, Inc. | 2012-07-18 | 77 | 0 |
| K113862 | ZIO PATCH | iRhythm Technologies, Inc. | 2012-02-06 | 38 | 0 |
| K091075 | ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM | iRhythm Technologies, Inc. | 2009-07-21 | 98 | 0 |
| K090363 | ZIO PATCH, MODEL Z100 | iRhythm Technologies, Inc. | 2009-05-08 | 84 | 0 |
| K081471 | ECARD AND CCARD | iRhythm Technologies, Inc. | 2008-06-24 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda