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

FDA lists 149 510(k) clearances, 0 PMA and 0 De Novo decisions across the 10 applicant names Caduvo groups under Convatec, first 1982, latest 2026. Median 510(k) review time across these names: 86 days. Since 2017 the median was 147 days, against 188 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 10 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 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.

Top product codes

Plus 24 more product codes.

Review panels

• General and Plastic Surgery (67)
• Gastroenterology and Urology (54)
• General Hospital (20)
• Anesthesiology (7)
• Cardiovascular (1)

Most recent Convatec 510(k) clearances

139 earlier clearances. See the full list in Caduvo.

Recalls

78 product recalls in 41 recall events under these names; 22 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.

ConvaTec was a Bristol-Myers Squibb division until 2008; its E.R. Squibb-era filings are included. Unomedical acquired 2008.

Sources

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

Frequently asked questions

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

FDA lists 149 510(k) clearances, 0 PMA and 0 De Novo decisions across the 10 applicant names Caduvo groups under Convatec, first 1982, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Convatec file under?

The names with the most 510(k) clearances in this group are Convatec, A Division of E.R. Squibb & Sons (84); Convatec (19); Unomedical A/S (13); Convatec, A Bristol-Myers Squibb Co. (10); Convatec Limited (10). The full list of 10 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 86 days. Since 2017 the median was 147 days, against 188 days for all cleared 510(k)s in the same product codes.

Does the Convatec 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 149 Convatec clearances with predicates and recalls
• Run predicate analysis for product code FRO, Convatec'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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