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

FDA lists 236 510(k) clearances, 12 PMA and 0 De Novo decisions across the 13 applicant names Caduvo groups under CooperCompanies, first 1978, latest 2026. Median 510(k) review time across these names: 87 days. Since 2017 the median was 74 days, against 125 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 13 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 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.

Top product codes

Plus 69 more product codes.

Review panels

• Ophthalmic (127)
• Obstetrics and Gynecology (78)
• General and Plastic Surgery (19)
• Radiology (6)
• Gastroenterology and Urology (4)
• General Hospital (4)
• Dental (2)
• Ear, Nose and Throat (2)
• Neurology (1)
• Physical Medicine (1)

Most recent CooperCompanies 510(k) clearances

226 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

162 product recalls in 88 recall events under these names; 43 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.

CooperVision and CooperSurgical, plus Ocular Sciences (2005), Origio (2012), Paragon Vision Sciences (2017). Includes filings made before each acquisition. Left out: COOPERVISION SURGICAL and COOPERVISION-CILCO (1970s–80s surgical businesses sold off). Cook Medical's reproductive health business (2022) is left out because it filed as COOK OB/GYN, which also covers older Cook products.

Sources

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

Frequently asked questions

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

FDA lists 236 510(k) clearances, 12 PMA and 0 De Novo decisions across the 13 applicant names Caduvo groups under CooperCompanies, first 1978, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does CooperCompanies file under?

The names with the most 510(k) clearances in this group are CooperVision, Inc. (97); CooperSurgical, Inc. (42); Wallach Surgical Devices, Inc. (27); Paragon Vision Sciences (16); Origio A/S (14). The full list of 13 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 87 days. Since 2017 the median was 74 days, against 125 days for all cleared 510(k)s in the same product codes.

Does the CooperCompanies 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 236 CooperCompanies clearances with predicates and recalls
• Run predicate analysis for product code LPL, CooperCompanies'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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