FDA product code NKK: Needle, Hypodermic, Single Lumen, Reprocessed
NKK is the FDA product code for needle, hypodermic, single lumen, reprocessed. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. Devices under NKK 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, Hypodermic, Single Lumen, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NKK devices
openFDA lists no recalls for product code NKK.
Frequently asked questions
What is FDA product code NKK?
NKK is the FDA product code for needle, hypodermic, single lumen, reprocessed. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is NKK?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NKK
- Run a recall and safety report across every NKK manufacturer
- Watch product code NKK 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.
All General Hospital product codes · FDA product code lookup