Briox Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Briox Technologies, Inc.” (first 1979, latest 1982), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 4 | 4 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Briox Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K813507 | INFALERT | BZQ | 1982-01-12 | 28 |
| K800078 | BRIOX MODEL-AEROMIST | — | 1980-02-05 | 22 |
| K791241 | BRIOX MODEL 2000-CA COMPRESSOR UNIT | JCX | 1979-07-24 | 18 |
| K791240 | BRIOX MODEL 2000-C COMPRESSOR UNIT | JCX | 1979-07-24 | 18 |
| K791239 | BRIOX MODEL 2000-A ASPIRATOR UNIT | JCX | 1979-07-24 | 18 |
| K791238 | BRIOX MODEL 2000-CQ QUIET COMPRESSOR | JCX | 1979-07-24 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Briox Technologies, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Briox Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Briox Technologies, Inc.” (first 1979, latest 1982), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Briox Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Briox Technologies, Inc. is 18 days.
Which FDA product codes appear under Briox Technologies, Inc.?
The most frequent FDA product codes under this applicant name are JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered, 4); BZQ (Monitor, Breathing Frequency, 1).
Next steps
- See all 6 Briox Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JCX, Briox Technologies, Inc.'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.