FDA applicant
Cook Biotech, Inc.
FDA records 47 decisions for Cook Biotech, Inc. (West Lafayette, IN) from 1998 to 2024: 47 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 99 predicates, 58 of them its own earlier devices. 16 recalls are linked to its devices.
FDA’s records also spell it “Cook Biotech Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cook Biotech, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
15in 2024
Class I Class II/III not classified
Planning a device like Cook Biotech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Cook”
FDA records each applicant name separately; these may or may not be the same firm.