Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Berkeley Advanced Biomaterials, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
261 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113791 | B-GENIN, R-GENIN | Berkeley Advanced Biomaterials, Inc. | 2012-03-15 | 84 | 0 |
| K091912 | B-GENIN AND R-GENIN | Berkeley Advanced Biomaterials, Inc. | 2010-06-23 | 363 | 0 |
| K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | Berkeley Advanced Biomaterials, Inc. | 2010-03-24 | 261 | 0 |
| K053213 | BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS | Berkeley Advanced Biomaterials, Inc. | 2006-07-06 | 232 | 0 |
| K051914 | GENEROS 80, GENEROS 60 | Berkeley Advanced Biomaterials, Inc. | 2005-11-03 | 112 | 0 |
| K051695 | MARROW PLUS (M+) | Berkeley Advanced Biomaterials, Inc. | 2005-07-19 | 26 | 0 |
| K050666 | GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-3 | Berkeley Advanced Biomaterials, Inc. | 2005-04-11 | 28 | 0 |
| K042636 | BIOPLUS | Berkeley Advanced Biomaterials, Inc. | 2004-12-14 | 78 | 0 |
| K041889 | TRI-OSTETIC | Berkeley Advanced Biomaterials, Inc. | 2004-08-19 | 38 | 0 |
| K040405 | CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY | Berkeley Advanced Biomaterials, Inc. | 2004-03-05 | 17 | 0 |
| K030266 | CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CE | Berkeley Advanced Biomaterials, Inc. | 2003-02-20 | 24 | 0 |
| K023703 | BI-OSTETIC | Berkeley Advanced Biomaterials, Inc. | 2003-01-30 | 87 | 0 |
| K022622 | CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, | Berkeley Advanced Biomaterials, Inc. | 2003-01-09 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda