FDA applicant
Berkeley Advanced Biomaterials, Inc.
FDA records 16 decisions for Berkeley Advanced Biomaterials, Inc. (Berkeley, CA) from 2003 to 2026: 16 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and KGN (Wound Dressing With Animal-Derived Material (S)). Since 2016 its 510(k)s took a median of 215 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Berkeley Advanced Biomaterials”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Berkeley Advanced Biomaterials, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Berkeley Advanced Biomaterials, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Berkeley”
FDA records each applicant name separately; these may or may not be the same firm.