# Kerecis Limited

- Location (FDA's records): Isafjordur, IS
- FDA decisions: 11 (2013–2025): 11 510(k) clearances
- Names in FDA's records: Kerecis Limited (10); Kerecis (1)
- Product codes: KGN (5), OXH (2), NPL (2), OXE (1), OWY (1)
- 510(k) review time since 2016: median 151 days, against 147 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 21 (9 its own); citations of its devices by later devices: 10 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook Biotech, Inc.: 2 (https://510kreport.com/company/cook-biotech)
- Integra LifeSciences Corporation: 2 (https://510kreport.com/company/integra-lifesciences)
- Ed. Geistlich Soehne AG Fur Chemische Industrie: 1 (https://510kreport.com/company/ed-geistlich-soehne-ag-fur-chemische-industrie)
- Synovis Surgical Innovations: 1 (https://510kreport.com/company/synovis-surgical-innovations)
- Mesynthes, Ltd.: 1 (https://510kreport.com/company/mesynthes)
- Acell, Inc.: 1 (https://510kreport.com/company/acell)
- Lifecell Corp.: 1 (https://510kreport.com/company/lifecell)
- Tei Biosciences, Inc.: 1 (https://510kreport.com/company/tei-biosciences)

## Firms that cite its devices most
- Acera Surgical, Inc.: 1 (https://510kreport.com/company/acera-surgical)

## Its most-cited devices
- K202430: Kerecis Reconstruct (2021), cited by 3
- K190528: MariGen Wound Extra (2019), cited by 3
- K132343: Marigen Wound Dressing (2013), cited by 2
- K213231: Kerecis Silicone (2022), cited by 1
- K241080: Kerecis Parvus (50207) (2024), cited by 1

## Recent decisions
- K251845: Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus (Jul 16, 2025)
- K251844: Kerecis SurgiBind (50241) (Jul 15, 2025)
- K243843: Tendon Protect (50242) (Jun 4, 2025)
- K241080: Kerecis Parvus (50207) (Aug 21, 2024)
- K213904: Kerecis Oral (Sep 30, 2022)
- K213231: Kerecis Silicone (Jun 29, 2022)
- K202430: Kerecis Reconstruct (May 2, 2021)
- K192612: Kerecis Gingiva Graft (Nov 13, 2020)

Source page: https://510kreport.com/company/kerecis