U.S. FDA De Novo Authorized
Class II Suction Anti-Choking Device — Second-Line Treatment
In March 2026, the U.S. FDA granted LifeVac De Novo authorization as a Class II suction anti-choking device for second-line treatment. LifeVac is intended for complete airway obstruction when current choking protocols have been followed without success, for adults and children at least 1 year of age.
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