510(k) DEN250012
DEN250012 is an FDA 510(k) premarket notification submitted by Lifevac, LLC for the device "LifeVac". The FDA issued a decision of De Novo Granted on Mar 4, 2026. The device falls under product code QXN (Suction Anti-Choking Device As A Second-Line Treatment), a Class II device regulated under 21 CFR 874.5400.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Mar 4, 2026
- Date Received
- Apr 11, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suction Anti-Choking Device As A Second-Line Treatment
- Device Class
- Class II
- Regulation Number
- 874.5400
- Review Panel
- EN
- Submission Type
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.