FDA Grants De Novo Classification to LifeVac Anti-Choking Device

The U.S. Food and Drug Administration has granted De Novo classification to the LifeVac suction anti-choking device under 21 CFR 874.5400, establishing a new medical device category for suction-based airway clearance systems.

Under the decision, LifeVac is classified as a Class II medical device intended to resolve choking caused by complete airway obstruction through suction. The FDA defines it as a second-line treatment, designed for use when standard basic life support (BLS) choking protocols have failed.

The device is a single-use, non-powered and non-invasive airway clearance tool suitable for adults and children aged one year and older. It can be operated by trained laypersons or healthcare professionals in settings such as homes, schools, restaurants and nursing homes.

According to the FDA, the Class II designation—combined with general and special controls—provides reasonable assurance of the device’s safety and effectiveness for emergency choking situations.

09-03-2026