Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Berkeley Bio-Engineering — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K790645 | ENDOTOME | Berkeley Bio-Engineering | 1979-04-23 | 24 | 0 |
| K771711 | BIOTOME | Berkeley Bio-Engineering | 1977-09-28 | 16 | 0 |
| K771644 | FRAGMATOME MODEL 820 | Berkeley Bio-Engineering | 1977-09-26 | 28 | 0 |
| K770292 | MONITOR, FETAL HEART, MODEL 1980 | Berkeley Bio-Engineering | 1977-03-09 | 23 | 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