FDA applicant
Reprise Biomedical, Inc.
FDA records 5 decisions for Reprise Biomedical, Inc. (Plymouth, MN) from 2022 to 2024: 5 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 31 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Reprise Biomedical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Reprise Biomedical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Reprise Biomedical, Inc.’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) Report