Berkeley Advanced Biomaterials, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Berkeley Advanced Biomaterials, Inc.” (first 2003, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 84 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 215 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 175 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Berkeley Advanced Biomaterials, Inc. took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 14 | 14 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
Review panels
Most recent Berkeley Advanced Biomaterials, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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) | KGN | 2026-08-27 | 175 |
| K170917 | Bi-Ostetic Bioactive Glass Foam | MQV | 2017-10-30 | 215 |
| K113791 | B-GENIN, R-GENIN | MQV | 2012-03-15 | 84 |
| K091912 | B-GENIN AND R-GENIN | MQV | 2010-06-23 | 363 |
| K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | MQV | 2010-03-24 | 261 |
| K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM | MQV | 2006-07-06 | 232 |
| K051914 | GENEROS 80, GENEROS 60 | MQV | 2005-11-03 | 112 |
| K051695 | MARROW PLUS (M+) | MQV | 2005-07-19 | 26 |
| K050666 | GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES | MQV | 2005-04-11 | 28 |
| K042636 | BIOPLUS | MQV | 2004-12-14 | 78 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Berkeley Advanced Biomaterials, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Berkeley Advanced Biomaterials, Inc. (13)
- Berkeley Advanced Biomaterials (2)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Berkeley Electric Wheelchair Co. (6 510(k)s)
- Berkeley Medevices (5 510(k)s)
- Berkeley Bio-Engineering (4 510(k)s)
- Berkeley Bio-Medical, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Berkeley Advanced Biomaterials, Inc.?
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Berkeley Advanced Biomaterials, Inc.” (first 2003, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Berkeley Advanced Biomaterials, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Berkeley Advanced Biomaterials, Inc. is 87 days.
Which FDA product codes appear under Berkeley Advanced Biomaterials, Inc.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 14); KGN (Wound Dressing With Animal-Derived Material(S), 1).
Next steps
- See all 15 Berkeley Advanced Biomaterials, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Berkeley Advanced Biomaterials, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.