Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Canadian Monaghan , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
211 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931394 | CM5000R REMOTE INDICATOR | Canadian Monaghan , Ltd. | 1993-07-01 | 104 | 0 |
| K931287 | CM7000 REMOTE INDICATOR | Canadian Monaghan , Ltd. | 1993-07-01 | 111 | 0 |
| K925673 | AIRWAY PRESSURE MONITOR CM 5000 NGAN | Canadian Monaghan , Ltd. | 1993-06-09 | 211 | 0 |
| K873953 | CM 5000R REMOTE AIRWAY PRESSURE | Canadian Monaghan , Ltd. | 1987-10-27 | 29 | 0 |
| K871083 | CM 5000 MONITOR AIRWAY PRESSURE | Canadian Monaghan , Ltd. | 1987-04-08 | 21 | 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