FDA product code KBQ: Knife, Tonsil
KBQ is the FDA product code for knife, tonsil. 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 KBQ. The average 510(k) review took 82 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Knife, Tonsil |
| 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 KBQ clearance
Top KBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Premier Dental Products Co. | 1 | 1984-05-30 |
Most recent KBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K841005 | Premier Dental Products Co. | TONSIL KNIFE-VARIOUS | 1984-05-30 | 82 |
Recalls for KBQ devices
openFDA lists no recalls for product code KBQ.
Frequently asked questions
What is FDA product code KBQ?
KBQ is the FDA product code for knife, tonsil. 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 KBQ?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBQ?
Across 1 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most KBQ clearances?
Premier Dental Products Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBQ
- Run a recall and safety report across every KBQ manufacturer
- Watch product code KBQ 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.
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