Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Berkley Medical Resources, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971744 | FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503) | Berkley Medical Resources, Inc. | 1997-07-28 | 77 | 0 |
| K962286 | 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD | Berkley Medical Resources, Inc. | 1996-10-07 | 115 | 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