FDA product code QXN: Suction Anti-Choking Device As A Second-Line Treatment
QXN is the FDA product code for suction anti-choking device as a second-line treatment. It is a Class II device, regulated under 21 CFR 874.5400 and reviewed by the Ear, Nose and Throat panel. Devices under QXN reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A suction anti-choking device as a second-line treatment is intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction. The device is intended to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol.
Classification
| Field | Value |
|---|---|
| Device name | Suction Anti-Choking Device As A Second-Line Treatment |
| Device class | Class II |
| Regulation | 21 CFR 874.5400 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for QXN devices
openFDA lists no recalls for product code QXN.
Frequently asked questions
What is FDA product code QXN?
QXN is the FDA product code for suction anti-choking device as a second-line treatment. It is a Class II device, regulated under 21 CFR 874.5400 and reviewed by the Ear, Nose and Throat panel.
What device class is QXN?
Class II, regulation 21 CFR 874.5400. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXN
- Run a recall and safety report across every QXN manufacturer
- Watch product code QXN 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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