FDA product code KBF: Trephine, Sinus
KBF is the FDA product code for trephine, sinus. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under KBF. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Trephine, Sinus |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KBF clearance
Top KBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Medical Products, Inc. | 1 | 1980-12-19 |
Most recent KBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802915 | Boston Medical Products, Inc. | MONTG. TRACHEAL TREPHINE FENE STRATOR | 1980-12-19 | 30 |
Recalls for KBF devices
openFDA lists no recalls for product code KBF.
Frequently asked questions
What is FDA product code KBF?
KBF is the FDA product code for trephine, sinus. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KBF?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBF?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most KBF clearances?
Boston Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBF
- Run a recall and safety report across every KBF manufacturer
- Watch product code KBF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times