Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcanica, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
191 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011373 | INSTRUMENT DAMPING PORT | Medcanica, Inc. | 2001-10-12 | 161 | 0 |
| K011349 | INTERCOSTAL LOCKABLE-DIRECTABLE PORT | Medcanica, Inc. | 2001-10-05 | 156 | 0 |
| K994232 | PHALANGEAL FIXATION SYSTEM | Medcanica, Inc. | 2000-03-01 | 76 | 0 |
| K991486 | ULTRA-CBX | Medcanica, Inc. | 1999-11-05 | 191 | 0 |
| K991064 | METACARPAL FIXATION SYSTEM | Medcanica, Inc. | 1999-06-23 | 84 | 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