Convatec: FDA filings under this applicant name

FDA lists 19 510(k) clearances under the applicant name “Convatec” (first 1997, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 152 days. Since 2017 the median was 152 days, against 176 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Convatec, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Convatec took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.

Top product codes

Review panels

• Gastroenterology and Urology (13)
• General and Plastic Surgery (5)
• Cardiovascular (1)

Most recent Convatec 510(k) clearances

9 earlier clearances. See the full list in Caduvo.

Recalls

72 product recalls in 37 recall events; 16 initiated in the last five years. Most recent: 2026-07-06.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Convatec is the lead sponsor of 32 device studies on ClinicalTrials.gov (6 active or recruiting). Most recent:

• NCT07209358: EDX110 Randomized Control Trial for Treatment of DFUs (Recruiting, started 2025-10-30)
• NCT06616844: IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers (Recruiting, started 2025-02-12)
• NCT06640985: EDX110 - Efficacy and Safety in the Management of Hard-to-heal Wounds (Active not recruiting, started 2024-12-04)
• NCT06606210: INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone (Recruiting, started 2024-09-19)
• NCT07170566: A Retrospective, Observational Study of the Real-world Safety and Performance of InnovaMatrix® AC at a Single Centre (Completed, started 2024-05-01)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Convatec, A Division of E.R. Squibb & Sons (84 510(k)s)
• Convatec, A Bristol-Myers Squibb Co. (10 510(k)s)
• Convatec Limited (10 510(k)s)
• Convatec Limited, Gdc Building (1 510(k)s)
• Convatec Triad Life Sciences, LLC (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Convatec?

FDA lists 19 510(k) clearances under the applicant name “Convatec” (first 1997, latest 2026), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Convatec?

The median time from FDA receipt to decision across 510(k)s cleared under the name Convatec is 152 days. Since 2017: 152 days, versus 176 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Convatec?

The most frequent FDA product codes under this applicant name are EZD (Catheter, Straight, 5); FRO (Dressing, Wound, Drug, 5); KNT (Tubes, Gastrointestinal (And Accessories), 4).

Next steps

• See all 19 Convatec clearances with predicates and recalls
• Run predicate analysis for product code EZD, Convatec's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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