FDA product code KBH: Adenotome
KBH is the FDA product code for adenotome. 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 KBH. The average 510(k) review took 27 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Adenotome |
| 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 KBH clearance
Top KBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-25 |
Most recent KBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822262 | Kelleher Corp. | ADENOTOMES | 1982-08-25 | 27 |
Recalls for KBH devices
openFDA lists no recalls for product code KBH.
Frequently asked questions
What is FDA product code KBH?
KBH is the FDA product code for adenotome. 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 KBH?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBH?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most KBH clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBH
- Run a recall and safety report across every KBH manufacturer
- Watch product code KBH 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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