FDA product code PWO: Blood Administration Kit
PWO is the FDA product code for blood administration kit. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. Devices under PWO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Blood Administration Kit |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PWO devices
openFDA lists no recalls for product code PWO.
Frequently asked questions
What is FDA product code PWO?
PWO is the FDA product code for blood administration kit. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is PWO?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PWO
- Run a recall and safety report across every PWO manufacturer
- Watch product code PWO 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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