QXN — Suction Anti-Choking Device As A Second-Line Treatment Class II
FDA product code QXN covers "Suction Anti-Choking Device As A Second-Line Treatment", a Class II medical device regulated under 21 CFR 874.5400. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXN
- Device Class
- Class II
- Regulation Number
- 874.5400
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250012 | Lifevac | LifeVac | Mar 4, 2026 |