Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Itamar Medical (C.M.) 1997 , Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010156 | SLEEP PAT 200 DEVICE | Itamar Medical (C.M.) 1997 , Ltd. | 2002-06-19 | 519 | 0 |
| K010739 | WATCH-PAT 100 | Itamar Medical (C.M.) 1997 , Ltd. | 2001-11-06 | 239 | 0 |
| K001852 | PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE | Itamar Medical (C.M.) 1997 , Ltd. | 2001-02-21 | 247 | 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