FDA product code KCL: Blower, Powder, Ent
KCL is the FDA product code for blower, powder, ent. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel. Devices under KCL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Blower, Powder, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.5220 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KCL devices
openFDA lists no recalls for product code KCL.
Frequently asked questions
What is FDA product code KCL?
KCL is the FDA product code for blower, powder, ent. It is a Class I device, regulated under 21 CFR 874.5220 and reviewed by the Ear, Nose and Throat panel.
What device class is KCL?
Class I, regulation 21 CFR 874.5220. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KCL
- Run a recall and safety report across every KCL manufacturer
- Watch product code KCL 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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