Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Itamar Medical — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
98 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081982 | WATCH-PAT 200S-2 (WP200S-2) | Itamar Medical | 2008-08-14 | 34 | 0 |
| K081037 | WATCH-PAT 200I (WP200I) | Itamar Medical | 2008-06-09 | 59 | 0 |
| K080427 | WATCH-PAT MODEL 100S-2 | Itamar Medical | 2008-05-23 | 98 | 0 |
| K042916 | WATCH PAT 100S | Itamar Medical | 2004-12-29 | 69 | 0 |
| K032519 | ENDO PAT 2000 | Itamar Medical | 2003-11-12 | 89 | 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