FDA product code PXE: Pressure Monitoring (Air/Gas) Kit
PXE is the FDA product code for pressure monitoring (air/gas) kit. It is a Class I device, regulated under 21 CFR 868.2610 and reviewed by the Anesthesiology panel. Devices under PXE 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 | Pressure Monitoring (Air/Gas) Kit |
| Device class | Class I |
| Regulation | 21 CFR 868.2610 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for PXE devices
openFDA lists no recalls for product code PXE.
Frequently asked questions
What is FDA product code PXE?
PXE is the FDA product code for pressure monitoring (air/gas) kit. It is a Class I device, regulated under 21 CFR 868.2610 and reviewed by the Anesthesiology panel.
What device class is PXE?
Class I, regulation 21 CFR 868.2610. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PXE
- Run a recall and safety report across every PXE manufacturer
- Watch product code PXE 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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