B & F Medical Products, Inc.: FDA clearances and approvals
B & F Medical Products, Inc. has 18 FDA 510(k) clearances (first 1976, latest 1994), across 15 product codes in 2 review panels. Median 510(k) review time: 46 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | 3 | 3 |
| CAW | Generator, Oxygen, Portable | 2 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 1 | 1 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
| BYO | Bottle, Blow | 1 | 1 |
| BYX | Tubing, Pressure And Accessories | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| CAN | Regulator, Pressure, Gas Cylinder | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
Plus 5 more product codes.
Review panels
- Anesthesiology (16)
- General Hospital (1)
Most recent B & F Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942645 | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | BXH | 1994-07-27 | 54 |
| K920573 | CANNULA NASAL OXYGEN | CAT | 1992-08-11 | 186 |
| K913501 | TRACHEOSTOMY MASK | BYG | 1992-01-13 | 159 |
| K861325 | MAXI-USE O2 DEVICE | NFB | 1986-09-09 | 153 |
| K861054 | DISPOSABLE RESCUE BREATHING DEVICE | CAE | 1986-04-09 | 21 |
| K853004 | PORTABLE OXYGEN UNIT | CAW | 1985-08-29 | 44 |
| K843691 | PORTABLE OXYGEN UNIT | CAW | 1984-11-07 | 49 |
| K823532 | STOCK #64091-PEDIATRIC OXYGEN MASK | BYG | 1983-01-05 | 37 |
| K811404 | TRAVELAIRE | CCQ | 1981-06-09 | 22 |
| K802644 | EMERG. OXYGEN KIT #65350 & #65399 CASE | CAN | 1980-12-22 | 59 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named B & F Medical Products, 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 B & F Medical Products, Inc. have?
B & F Medical Products, Inc. has 18 FDA 510(k) clearances (first 1976, latest 1994), across 15 product codes in 2 review panels.
How long does FDA take to clear B & F Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across B & F Medical Products, Inc.'s cleared 510(k)s is 46 days.
What devices does B & F Medical Products, Inc. make?
Its most frequent FDA product codes are BYG (Mask, Oxygen, 3); CAW (Generator, Oxygen, Portable, 2); BWF (Spirometer, Therapeutic (Incentive), 1).
Has B & F Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching B & F Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 18 B & F Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYG, B & F Medical Products, 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.