FDA product code NMP: Needle, Isotope, Reprocessed
NMP is the FDA product code for needle, isotope, reprocessed. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel. Devices under NMP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Isotope, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 892.5730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for NMP devices
openFDA lists no recalls for product code NMP.
Frequently asked questions
What is FDA product code NMP?
NMP is the FDA product code for needle, isotope, reprocessed. It is a Class II device, regulated under 21 CFR 892.5730 and reviewed by the Radiology panel.
What device class is NMP?
Class II, regulation 21 CFR 892.5730. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NMP
- Run a recall and safety report across every NMP manufacturer
- Watch product code NMP 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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