FDA product code MKB: Device, Germicidal, Ultraviolet
MKB is the FDA product code for device, germicidal, ultraviolet. It is a Class II device, regulated under 21 CFR 880.6500 and reviewed by the General Hospital panel. Devices under MKB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Germicidal, Ultraviolet |
| Device class | Class II |
| Regulation | 21 CFR 880.6500 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MKB devices
openFDA lists no recalls for product code MKB.
Frequently asked questions
What is FDA product code MKB?
MKB is the FDA product code for device, germicidal, ultraviolet. It is a Class II device, regulated under 21 CFR 880.6500 and reviewed by the General Hospital panel.
What device class is MKB?
Class II, regulation 21 CFR 880.6500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MKB
- Run a recall and safety report across every MKB manufacturer
- Watch product code MKB 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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