FDA product code PHS: Oral Airway Assist
PHS is the FDA product code for oral airway assist. It is a Class I device, regulated under 21 CFR 868.5110 and reviewed by the Anesthesiology panel. Devices under PHS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
To assist in maintaining an open airway.
Classification
| Field | Value |
|---|---|
| Device name | Oral Airway Assist |
| Device class | Class I |
| Regulation | 21 CFR 868.5110 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Recalls for PHS devices
openFDA lists no recalls for product code PHS.
Frequently asked questions
What is FDA product code PHS?
PHS is the FDA product code for oral airway assist. It is a Class I device, regulated under 21 CFR 868.5110 and reviewed by the Anesthesiology panel.
What device class is PHS?
Class I, regulation 21 CFR 868.5110. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PHS
- Run a recall and safety report across every PHS manufacturer
- Watch product code PHS 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.