Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cook Biotech Incorprated — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150668 | Biodesign Enterocutaneous Fistula Plug | Cook Biotech Incorprated | 2015-12-09 | 268 | 0 |
| K142887 | SIS Inguinal Hernia Repair Graft | Cook Biotech Incorprated | 2015-10-01 | 364 | 0 |
| K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015-09-16 | 191 | 0 |
| K121360 | BIODESIGN ENT REPAIR GRAFT | Cook Biotech Incorprated | 2013-02-27 | 296 | 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