FDA product code POR: Parenteral Administration Kit
POR is the FDA product code for parenteral administration kit. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. Devices under POR 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Classification
| Field | Value |
|---|---|
| Device name | Parenteral 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 POR devices
openFDA lists no recalls for product code POR.
Frequently asked questions
What is FDA product code POR?
POR is the FDA product code for parenteral 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 POR?
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 POR
- Run a recall and safety report across every POR manufacturer
- Watch product code POR 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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