510(k) DEN250012

LifeVac by Lifevac, LLC — Product Code QXN

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: March 4, 2026
Date Received: April 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.