Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Itamar Medical , Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
227 daysmedian FDA review time
446 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254042 | WatchPAT SW | Itamar Medical , Ltd. | 2026-07-31 | 227 | 0 |
| K250460 | WatchPAT400 (WP400) | Itamar Medical , Ltd. | 2025-09-05 | 199 | 0 |
| K223675 | WatchPAT ONE (WP1) | Itamar Medical , Ltd. | 2023-01-06 | 30 | 0 |
| K211557 | EndoPATx | Itamar Medical , Ltd. | 2022-12-29 | 589 | 0 |
| K222331 | WatchPAT300 (WP300) | Itamar Medical , Ltd. | 2022-09-14 | 43 | 0 |
| K203839 | WatchPAT200U (WP200U) | Itamar Medical , Ltd. | 2022-03-21 | 446 | 0 |
| K183559 | WatchPAT ONE | Itamar Medical , Ltd. | 2019-06-05 | 167 | 0 |
| K180775 | Watch-PAT300 | Itamar Medical , Ltd. | 2018-08-17 | 147 | 0 |
| K161579 | Watch-PAT200U | Itamar Medical , Ltd. | 2017-02-24 | 262 | 0 |
| K153070 | Watch-PAT200U | Itamar Medical , Ltd. | 2016-07-26 | 278 | 0 |
| K133859 | WATCH-PAT200U (WP200U) | Itamar Medical , Ltd. | 2014-05-30 | 162 | 0 |
| K102567 | WATCH-PAT 200S-3 (WP200S-3) | Itamar Medical , Ltd. | 2011-06-02 | 268 | 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