FDA product code KBM: Dissector, Tonsil
KBM is the FDA product code for dissector, 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 KBM. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Dissector, 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 KBM clearance
Top KBM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Insights, Inc. | 1 | 1994-04-14 |
Most recent KBM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940903 | Medical Insights, Inc. | TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES | 1994-04-14 | 49 |
Recalls for KBM devices
openFDA lists no recalls for product code KBM.
Frequently asked questions
What is FDA product code KBM?
KBM is the FDA product code for dissector, 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 KBM?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBM?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most KBM clearances?
Medical Insights, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBM
- Run a recall and safety report across every KBM manufacturer
- Watch product code KBM 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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