# KGN: Wound Dressing With Animal-Derived Material (S)

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 194
- 510(k) review time 2021–2025: median 178 days (middle half 84–273)
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 7
- 2018: 6
- 2019: 3
- 2020: 5
- 2021: 6
- 2022: 12
- 2023: 9
- 2024: 13
- 2025: 10
- 2026: 15

## Most-cited predicates
- K061711: Oasis Wound Matrix (2006), cited by 16
- K993948: Sis Wound Dressing II (2000), cited by 10
- K910944: Medifil (1991), cited by 10
- K022127: Avagen Wound Dressing (2002), cited by 10
- K021792: Bilayer Matrix Wound Dressing (2002), cited by 9
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate (1998), cited by 8
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram (1999), cited by 8
- K012990: Collatek Powder (2001), cited by 8
- K030921: Collagen Topical Wound Dressing (2003), cited by 7
- K092096: Endoform Dermal Template (2010), cited by 6

Source page: https://510kreport.com/product-code/KGN
Data by year (CSV): https://510kreport.com/product-code/KGN.csv