Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Berkeley Medevices — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
88 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892220 | LAMINARIA TENT | Berkeley Medevices | 1989-06-14 | 72 | 0 |
| K840952 | MEDEVICE V-80 VACUUM PUMP | Berkeley Medevices | 1984-03-30 | 25 | 0 |
| K823006 | MEDEVICES ASPIRATION HOSE | Berkeley Medevices | 1982-11-04 | 23 | 0 |
| K812389 | SURGICAL LOOPS | Berkeley Medevices | 1981-11-16 | 88 | 0 |
| K812388 | SURGICAL PAWS | Berkeley Medevices | 1981-11-16 | 88 | 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