FDA applicant
Coloplast Corp.
FDA records 73 decisions for Coloplast Corp. (Plymouth, MN) from 1972 to 2026: 70 510(k) clearances and 3 original PMA approvals. Most are in product codes EZD (Catheter, Straight) and GBM (Catheter, Urethral). Since 2016 its 510(k)s took a median of 190 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 81 predicates, 29 of them its own earlier devices. 23 recalls are linked to its devices.
FDA’s records also spell it “Coloplast”, “Coloplast A.S.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Coloplast Corp.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Coloplast Corp.’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 “Coloplast”
FDA records each applicant name separately; these may or may not be the same firm.