Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Browne Medical Systems, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
131 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | Browne Medical Systems, Inc. | 1992-04-10 | 56 | 0 |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | Browne Medical Systems, Inc. | 1992-04-10 | 56 | 0 |
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | Browne Medical Systems, Inc. | 1992-04-10 | 56 | 0 |
| K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO | Browne Medical Systems, Inc. | 1991-06-10 | 131 | 0 |
| K910371 | URODYNAMIC MEASURING SYSTEM | Browne Medical Systems, Inc. | 1991-05-15 | 106 | 0 |
| K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM | Browne Medical Systems, Inc. | 1991-04-02 | 75 | 0 |
| K910285 | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP | Browne Medical Systems, Inc. | 1991-04-02 | 70 | 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