FDA applicant
Cook, Inc.
FDA records 371 decisions for Cook, Inc. (Bloomington, IN) from 1976 to 2024: 364 510(k) clearances, 1 De Novo grant and 6 original PMA approvals. Most are in product codes DQX (Wire, Guide, Catheter) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 239 days from receipt to decision, against 166 for FDA’s reviews in the same codes and years. Its devices cite 362 predicates, 175 of them its own earlier devices. 494 recalls are linked to its devices, 38 Class I.
FDA’s records also spell it “Cook Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cook, 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 2026
Class I Class II/III not classified
Planning a device like Cook, 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.