FDA product code PUK: Administration Set Securement Device
PUK is the FDA product code for administration set securement device. It is a Class I device, regulated under 21 CFR 880.5210 and reviewed by the General Hospital panel. Devices under PUK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices.
Classification
| Field | Value |
|---|---|
| Device name | Administration Set Securement Device |
| Device class | Class I |
| Regulation | 21 CFR 880.5210 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PUK devices
openFDA lists no recalls for product code PUK.
Frequently asked questions
What is FDA product code PUK?
PUK is the FDA product code for administration set securement device. It is a Class I device, regulated under 21 CFR 880.5210 and reviewed by the General Hospital panel.
What device class is PUK?
Class I, regulation 21 CFR 880.5210. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PUK
- Run a recall and safety report across every PUK manufacturer
- Watch product code PUK 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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