FDA applicant
Convatec Limited
FDA records 29 decisions for Convatec Limited (Deeside, GB) from 1997 to 2026: 29 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and EZD (Catheter, Straight). Since 2016 its 510(k)s took a median of 152 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 40 predicates, 18 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Convatec”, “Convatec, Inc.”, “Convatec, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Convatec Limited’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Convatec Limited’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 “Convatec”
FDA records each applicant name separately; these may or may not be the same firm.