Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Canyon Medical Products · 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) |
|---|---|---|---|---|---|
| K954181 | CANYONS BI-DIRECTIONAL CHECK VALVE | Canyon Medical Products | 1995-11-29 | 84 | 0 |
| K897026 | CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO. | Canyon Medical Products | 1990-02-26 | 69 | 0 |
| K874899 | CANYON MEDICAL FEMORAL BYPASS CANNULAE | Canyon Medical Products | 1988-02-18 | 79 | 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