Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cook Biotech Incorporated · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
267 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); B | Cook Biotech Incorporated | 2024-05-24 | 268 | 1 |
| K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2020-07-13 | 88 | 0 |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesi | Cook Biotech Incorporated | 2019-12-27 | 185 | 0 |
| K171817 | Biodesign Diaphragmatic Hernia Graft | Cook Biotech Incorporated | 2018-03-13 | 267 | 0 |
| K162934 | Biodesign Parastomal Hernia Repair Graft | Cook Biotech Incorporated | 2017-07-10 | 263 | 0 |
| K170016 | Biodesign Fistula Plug | Cook Biotech Incorporated | 2017-06-21 | 169 | 0 |
| K170945 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2017-04-28 | 29 | 0 |
| K161762 | DynaMatrix/Dynamatrix Plus | Cook Biotech Incorporated | 2017-01-13 | 200 | 0 |
| K162741 | AxoGuard Nerve Connector | Cook Biotech Incorporated | 2016-10-31 | 31 | 0 |
| K160136 | Flowable Wound Matrix | Cook Biotech Incorporated | 2016-09-28 | 252 | 0 |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign | Cook Biotech Incorporated | 2016-05-26 | 27 | 0 |
| K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | 2016-05-11 | 30 | 0 |
| K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Pey | Cook Biotech Incorporated | 2016-04-29 | 30 | 1 |
| K152033 | Cook ECM Powder | Cook Biotech Incorporated | 2015-08-19 | 28 | 0 |
| K132660 | NERVE CUFF | Cook Biotech Incorporated | 2014-01-10 | 137 | 0 |
| K130006 | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS | Cook Biotech Incorporated | 2013-04-05 | 93 | 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