# Berkeley Advanced Biomaterials, Inc.

- Location (FDA's records): Berkeley, CA
- FDA decisions: 16 (2003–2026): 16 510(k) clearances
- Names in FDA's records: Berkeley Advanced Biomaterials, Inc. (13); Berkeley Advanced Biomaterials (3)
- Product codes: MQV (14), KGN (2)
- 510(k) review time since 2016: median 215 days, against 174 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Regeneration Technologies, Inc.: 1 (https://510kreport.com/company/regeneration-technologies)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- R and D Medical, LLC: 1 (https://510kreport.com/company/r-and-d-medical)
- Orthovita, Inc.: 1 (https://510kreport.com/company/orthovita)
- Novabone Products, LLC: 1 (https://510kreport.com/company/novabone-products)

## Firms that cite its devices most
- R and D Medical, LLC: 1 (https://510kreport.com/company/r-and-d-medical)
- Takiron Co., Ltd.: 1 (https://510kreport.com/company/takiron)
- Ebi, L.P.: 1 (https://510kreport.com/company/ebi)
- Biocomposites, Ltd.: 1 (https://510kreport.com/company/biocomposites)
- Bonesupport AB: 1 (https://510kreport.com/company/bonesupport)
- Calcitec, Inc.: 1 (https://510kreport.com/company/calcitec)
- Teknimed, S.A.: 1 (https://510kreport.com/company/teknimed)

## Its most-cited devices
- K023703: BI-Ostetic (2003), cited by 4
- K022622: Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30P (2003), cited by 3
- K040405: Cem-Ostetic Putty Injection Kit, Model Pik-XX, Pik-XX-YY (2004), cited by 1
- K091912: B-Genin and R-Genin (2010), cited by 1
- K092046: BI-Ostetic Foam and Putty, Generos Foam and Putty (2010), cited by 1
- K051695: Marrow Plus (M+) (2005), cited by 1

## Recent decisions
- K260920: Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA); Accelagen Advanced Surgical Collagen Matrix, 3cc (CG-03AA); Accelagen Advanced Surgical Collagen Matrix, 5cc (CG-05AA); Accelagen Advanced Surgical Collagen Strip, 125x25x2mm (CG-125X25AA); Accelagen Advanced Surgical Collagen Strip, 250x25x2mm (CG-250X25AA) (Oct 22, 2026)
- K260711: Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) (Aug 27, 2026)
- K170917: Bi-Ostetic Bioactive Glass Foam (Oct 30, 2017)
- K113791: B-Genin, R-Genin (Mar 15, 2012)
- K091912: B-Genin and R-Genin (Jun 23, 2010)
- K092046: BI-Ostetic Foam and Putty, Generos Foam and Putty (Mar 24, 2010)
- K053213: BI-Ostetic Foam, Cem-Ostetic Foam, Tri-Ostetic Foam, Generos Foam (Jul 6, 2006)
- K051914: Generos 80, Generos 60 (Nov 3, 2005)

Source page: https://510kreport.com/company/berkeley-advanced-biomaterials