FDA product code PMB: External Airway
PMB is the FDA product code for external airway. It is a Class II device, regulated under 21 CFR 868.5105 and reviewed by the Anesthesiology panel. Devices under PMB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
Classification
| Field | Value |
|---|---|
| Device name | External Airway |
| Device class | Class II |
| Regulation | 21 CFR 868.5105 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Recalls for PMB devices
openFDA lists no recalls for product code PMB.
Frequently asked questions
What is FDA product code PMB?
PMB is the FDA product code for external airway. It is a Class II device, regulated under 21 CFR 868.5105 and reviewed by the Anesthesiology panel.
What device class is PMB?
Class II, regulation 21 CFR 868.5105. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PMB
- Run a recall and safety report across every PMB manufacturer
- Watch product code PMB 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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