Browne Medical Systems, Inc.: FDA clearances and approvals
Browne Medical Systems, Inc. has 7 FDA 510(k) clearances (first 1991, latest 1992), across 1 product code in 1 review panel. Median 510(k) review time: 70 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 7 | 7 |
Review panels
Most recent Browne Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | FAP | 1992-04-10 | 56 |
| K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | FAP | 1992-04-10 | 56 |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | FAP | 1992-04-10 | 56 |
| K910444 | BROWNE MEDICAL SYSTEMS IMAGEPRO | FAP | 1991-06-10 | 131 |
| K910371 | URODYNAMIC MEASURING SYSTEM | FAP | 1991-05-15 | 106 |
| K910285 | BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP | FAP | 1991-04-02 | 70 |
| K910217 | MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM | FAP | 1991-04-02 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Browne Medical Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Browne Medical Systems, Inc. have?
Browne Medical Systems, Inc. has 7 FDA 510(k) clearances (first 1991, latest 1992), across 1 product code in 1 review panel.
How long does FDA take to clear Browne Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Browne Medical Systems, Inc.'s cleared 510(k)s is 70 days.
What devices does Browne Medical Systems, Inc. make?
Its most frequent FDA product codes are FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 7).
Has Browne Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Browne Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 7 Browne Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAP, Browne Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.