Cook Medical: FDA 510(k) clearances across all its applicant names

FDA lists 531 510(k) clearances, 10 PMA and 3 De Novo decisions across the 16 applicant names Caduvo groups under Cook Medical, first 1981, latest 2026. Median 510(k) review time across these names: 106 days. Since 2017 the median was 215 days, against 122 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 16 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 215 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.

Top product codes

Plus 128 more product codes.

Review panels

• Gastroenterology and Urology (266)
• Cardiovascular (135)
• Obstetrics and Gynecology (68)
• General and Plastic Surgery (38)
• Anesthesiology (12)
• General Hospital (12)
• Ear, Nose and Throat (5)
• Radiology (4)
• Dental (1)
• Neurology (1)
• Physical Medicine (1)

Most recent Cook Medical 510(k) clearances

521 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

214 product recalls in 80 recall events under these names; 108 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Privately held Cook Group. Left out: Cook OB/GYN (reproductive health sold to CooperSurgical 2022), Cook Biotech (separately held; relationship to Cook Medical needs review), Cook-Waite (dental anesthetics, unrelated). The plain COOK name is left out because it could not be confirmed as Cook Incorporated.

Sources

• https://en.wikipedia.org/wiki/Cook_Medical

Frequently asked questions

How many FDA 510(k) clearances are listed across Cook Medical's applicant names?

FDA lists 531 510(k) clearances, 10 PMA and 3 De Novo decisions across the 16 applicant names Caduvo groups under Cook Medical, first 1981, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Cook Medical file under?

The names with the most 510(k) clearances in this group are Cook Incorporated (174); Wilson-Cook Medical, Inc. (125); Cook Urological, Inc. (104); Cook Pacemaker Corp. (34); Cook Ireland, Ltd. (33). The full list of 16 names is on this page.

How long does FDA take to clear Cook Medical 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 106 days. Since 2017 the median was 215 days, against 122 days for all cleared 510(k)s in the same product codes.

Does the Cook Medical count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 531 Cook Medical clearances with predicates and recalls
• Run predicate analysis for product code FGE, Cook Medical's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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