FDA product code KBL: Depressor, Metal Tongue, Surgical
KBL is the FDA product code for depressor, metal tongue, surgical. 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 KBL. The average 510(k) review took 24 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Depressor, Metal Tongue, Surgical |
| 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 KBL clearance
Top KBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-16 |
Most recent KBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822184 | Kelleher Corp. | ENT METAL TONGUE DEPRESSORS | 1982-08-16 | 24 |
Recalls for KBL devices
openFDA lists no recalls for product code KBL.
Frequently asked questions
What is FDA product code KBL?
KBL is the FDA product code for depressor, metal tongue, surgical. 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 KBL?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBL?
Across 1 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most KBL clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBL
- Run a recall and safety report across every KBL manufacturer
- Watch product code KBL 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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