FDA applicant
Geniphys, Inc.
FDA records 1 decision for Geniphys, Inc. (Indianapolis, IN) in 2025: 1 510(k) clearance. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Geniphys, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2025high 1 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Geniphys, 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