Browne Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Browne Corp.” (first 1979, latest 1979), across 1 product code in 1 review panel. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792094 | BROWNE MODEL UA-6 | FAP | 1979-12-06 | 50 |
| K792093 | BROWNE MODEL GD-5 | FAP | 1979-12-06 | 50 |
| K792092 | BROWNE MODEL UD-4E | FAP | 1979-12-06 | 50 |
| K792091 | BROWNE MODEL UD-4D | FAP | 1979-12-06 | 50 |
| K792090 | BROWNE MODEL UD-4 | FAP | 1979-12-06 | 50 |
| K790754 | BROWNE MODEL CF-1 AND CF-1G | FAP | 1979-06-01 | 45 |
| K790478 | BROWNE MODEL UD-4DE | FAP | 1979-06-01 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Browne Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Browne Medical Systems, Inc. (7 510(k)s)
- Browne Medical, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Browne Corp.?
FDA lists 7 510(k) clearances under the applicant name “Browne Corp.” (first 1979, latest 1979), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Browne Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Browne Corp. is 50 days.
Which FDA product codes appear under Browne Corp.?
The most frequent FDA product codes under this applicant name are FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 7).
Next steps
- See all 7 Browne Corp. clearances with predicates and recalls
- Run predicate analysis for product code FAP, Browne Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.