Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Browne Medical, Inc. — 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) |
|---|---|---|---|---|---|
| K851483 | UROBEI STRESS INCONTINENCE MONITOR | Browne Medical, Inc. | 1985-08-07 | 114 | 0 |
| K834503 | PROFILE URODYNAMIC MONITORING SYS | Browne Medical, Inc. | 1984-02-21 | 62 | 0 |
| K833043 | UROMETER | Browne Medical, Inc. | 1984-02-04 | 151 | 0 |
| K830221 | BEDSIDE N.P.T. 9900 - PRINTER 9800 | Browne Medical, Inc. | 1983-03-17 | 52 | 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