Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
B & F Medical Products, Inc. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
159 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942645 | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG | B & F Medical Products, Inc. | 1994-07-27 | 54 | 0 |
| K920573 | CANNULA NASAL OXYGEN | B & F Medical Products, Inc. | 1992-08-11 | 186 | 0 |
| K913501 | TRACHEOSTOMY MASK | B & F Medical Products, Inc. | 1992-01-13 | 159 | 0 |
| K861325 | MAXI-USE O2 DEVICE | B & F Medical Products, Inc. | 1986-09-09 | 153 | 0 |
| K861054 | DISPOSABLE RESCUE BREATHING DEVICE | B & F Medical Products, Inc. | 1986-04-09 | 21 | 0 |
| K853004 | PORTABLE OXYGEN UNIT | B & F Medical Products, Inc. | 1985-08-29 | 44 | 0 |
| K843691 | PORTABLE OXYGEN UNIT | B & F Medical Products, Inc. | 1984-11-07 | 49 | 0 |
| K823532 | STOCK #64091-PEDIATRIC OXYGEN MASK | B & F Medical Products, Inc. | 1983-01-05 | 37 | 0 |
| K811404 | TRAVELAIRE | B & F Medical Products, Inc. | 1981-06-09 | 22 | 0 |
| K802644 | EMERG. OXYGEN KIT #65350 & #65399 CASE | B & F Medical Products, Inc. | 1980-12-22 | 59 | 0 |
| K802646 | HAND PERCUSSOR CUP #65210 | B & F Medical Products, Inc. | 1980-11-12 | 19 | 0 |
| K800664 | SURE FLOW TUBING | B & F Medical Products, Inc. | 1980-04-02 | 7 | 0 |
| K800665 | FIBERGLASS CYLINDER BASES, #'S 65040- | B & F Medical Products, Inc. | 1980-04-02 | 7 | 0 |
| K791646 | PLASTIC SHOWER GUARD | B & F Medical Products, Inc. | 1979-10-01 | 38 | 0 |
| K781731 | INCENT-O-NEB | B & F Medical Products, Inc. | 1978-12-05 | 54 | 0 |
| K780558 | BOTTLE BREATHING DEVICE | B & F Medical Products, Inc. | 1978-05-26 | 51 | 0 |
| K772141 | AEROSOL & OXYGEN MASKS | B & F Medical Products, Inc. | 1978-01-03 | 50 | 0 |
| K760680 | INTERMITTENT MANDATORY VENTILATION | B & F Medical Products, Inc. | 1976-09-27 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda