Tri/Bor Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tri/Bor Medical, Inc.” (first 1991, latest 1991), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| BYG | Mask, Oxygen | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Tri/Bor Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904718 | AERO-GEN NUBULIZER SYSTEM | CAF | 1991-04-01 | 165 |
| K904717 | MICRO-VENT NEBULIZER SYSTEM | CAF | 1991-04-01 | 165 |
| K904719 | DISPOSABLE FACE MASK | BYG | 1991-01-02 | 76 |
| K904716 | AERO-GEN NEBULIZER | CAF | 1991-01-02 | 76 |
| K904715 | OXYGEN/AIR TUBING | CAF | 1991-01-02 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Tri/Bor Medical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Tri/Bor Medical, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Tri/Bor Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Tri/Bor Medical, Inc.” (first 1991, latest 1991), across 2 product codes 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 Tri/Bor Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tri/Bor Medical, Inc. is 76 days.
Which FDA product codes appear under Tri/Bor Medical, Inc.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 4); BYG (Mask, Oxygen, 1).
Next steps
- See all 5 Tri/Bor Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Tri/Bor Medical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.