FDA product code QPK: Eua Faceshields
QPK is the FDA product code for eua faceshields. It is a Not classified device, reviewed by the General Hospital panel. Devices under QPK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Authorized faceshields intended for use during the declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Eua Faceshields |
| Device class | Not classified |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for QPK devices
openFDA lists no recalls for product code QPK.
Frequently asked questions
What is FDA product code QPK?
QPK is the FDA product code for eua faceshields. It is a Not classified device, reviewed by the General Hospital panel.
What device class is QPK?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QPK
- Run a recall and safety report across every QPK manufacturer
- Watch product code QPK 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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