FDA product code NKP: Injector, Contrast Medium, Automatic, Reprocessed
NKP is the FDA product code for injector, contrast medium, automatic, reprocessed. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel. Devices under NKP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Injector, Contrast Medium, Automatic, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1650 |
| Review panel | HO — General Hospital |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NKP devices
openFDA lists no recalls for product code NKP.
Frequently asked questions
What is FDA product code NKP?
NKP is the FDA product code for injector, contrast medium, automatic, reprocessed. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the General Hospital panel.
What device class is NKP?
Class II, regulation 21 CFR 870.1650. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKP
- Run a recall and safety report across every NKP manufacturer
- Watch product code NKP 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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