FDA product code FOD: Device, Occlusion, Umbilical
FOD is the FDA product code for device, occlusion, umbilical. It is a Class I device, regulated under 21 CFR 880.5950 and reviewed by the General Hospital panel. Devices under FOD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Occlusion, Umbilical |
| Device class | Class I |
| Regulation | 21 CFR 880.5950 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for FOD devices
openFDA lists no recalls for product code FOD.
Frequently asked questions
What is FDA product code FOD?
FOD is the FDA product code for device, occlusion, umbilical. It is a Class I device, regulated under 21 CFR 880.5950 and reviewed by the General Hospital panel.
What device class is FOD?
Class I, regulation 21 CFR 880.5950. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FOD
- Run a recall and safety report across every FOD manufacturer
- Watch product code FOD 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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