FDA product code PMQ: Peripheral Blood Processing Device For Wound Management
PMQ is the FDA product code for peripheral blood processing device for wound management. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel. Devices under PMQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management.
Classification
| Field | Value |
|---|---|
| Device name | Peripheral Blood Processing Device For Wound Management |
| Device class | Class II |
| Regulation | 21 CFR 864.9245 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Recalls for PMQ devices
openFDA lists no recalls for product code PMQ.
Frequently asked questions
What is FDA product code PMQ?
PMQ is the FDA product code for peripheral blood processing device for wound management. It is a Class II device, regulated under 21 CFR 864.9245 and reviewed by the Hematology panel.
What device class is PMQ?
Class II, regulation 21 CFR 864.9245. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PMQ
- Run a recall and safety report across every PMQ manufacturer
- Watch product code PMQ 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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