# DEN250012: LifeVac

- Pathway: De Novo (Direct)
- Applicant: Lifevac, LLC
- Decided: Mar 4, 2026 after 327 days
- Product code: QXN (Suction Anti-Choking Device As A Second-Line Treatment)
- Device class: 2
- Regulation: 21 CFR 874.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The LifeVac is a non-powered, non-invasive, single-use-only airway clearance device intended to resolve choking in a victim with a complete airway obstruction when a current choking protocol has been followed without success. LifeVac should only be used to remove an object/food from a victim with a complete airway obstruction. LifeVac is intended for use on adult or pediatric choking victims who are at least 1 year of age. LifeVac can be administered by a lay person or a medical professional (18 years or older) in various settings including at home or nursing homes, restaurants, schools, and other outside environments.

Source page: https://510kreport.com/device/DEN250012
Methodology: https://510kreport.com/methodology