FDA product code JFE: Valve, Switching (Ploss)
JFE is the FDA product code for valve, switching (ploss). It is a Class I device, regulated under 21 CFR 868.1965 and reviewed by the Anesthesiology panel. Devices under JFE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Valve, Switching (Ploss) |
| Device class | Class I |
| Regulation | 21 CFR 868.1965 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for JFE devices
openFDA lists no recalls for product code JFE.
Frequently asked questions
What is FDA product code JFE?
JFE is the FDA product code for valve, switching (ploss). It is a Class I device, regulated under 21 CFR 868.1965 and reviewed by the Anesthesiology panel.
What device class is JFE?
Class I, regulation 21 CFR 868.1965. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JFE
- Run a recall and safety report across every JFE manufacturer
- Watch product code JFE 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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