DEN250012 is an FDA 510(k) submission for the LifeVac. This device is classified as a Suction Anti-choking Device As A Second-line Treatment (Class II - Special Controls, product code QXN).
Submitted by Lifevac, LLC (Nesconset, US). The FDA issued a Not Cleared (DENG) decision on March 4, 2026.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.5400. 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..
| 510(k) Number | DEN250012 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 11, 2025 |
| Decision Date | March 04, 2026 |
| Days to Decision | 327 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | QXN — Suction Anti-choking Device As A Second-line Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.5400 |
| 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. |