FDA product code FRT: Unit, Isolation, Surgical
FRT is the FDA product code for unit, isolation, surgical. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel. Devices under FRT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Isolation, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.5070 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for FRT devices
openFDA lists no recalls for product code FRT.
Frequently asked questions
What is FDA product code FRT?
FRT is the FDA product code for unit, isolation, surgical. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel.
What device class is FRT?
Class II, regulation 21 CFR 878.5070. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code FRT
- Run a recall and safety report across every FRT manufacturer
- Watch product code FRT 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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