FDA Clears LifeVac as Second-Line Device for Choking Emergencies

A device designed to help clear a blocked airway during choking emergencies has received authorization from the U.S. Food and Drug Administration (FDA), marking a first for this type of medical technology.

LifeVac LLC announced that the FDA has granted de novo classification to its LifeVac device, formally establishing a new category of medical device called a suction anti-choking device used as a second-line treatment.

Under the decision, LifeVac is now classified as a Class II medical device, meaning it must meet specific safety and effectiveness standards set by the FDA. The agency defined this device type as one that uses suction to help remove an airway obstruction during a choking emergency, after standard basic life support choking protocols have been attempted but were unsuccessful.

The device is designed to be nonpowered, noninvasive, and single-use, and can be used for both adults and children over the age of 1. According to the authorization, the device may be used by either trained medical professionals or laypersons aged 18 and older in a variety of settings, including homes, schools, restaurants and nursing homes.

The FDA determined that classifying suction anti-choking devices in Class II, along with certain regulatory controls, provides reasonable assurance that the devices can be used safely and effectively for their intended purpose.

Company leaders say the decision establishes a clearer regulatory framework for devices designed to assist during choking emergencies.

The device is not intended to replace standard choking response techniques. Instead, it is meant to be used after basic life support methods, such as abdominal thrusts or back blows, have failed to dislodge an obstruction.

Choking remains a significant public health concern, particularly for young children and older adults. Emergency response guidance typically emphasizes quick recognition of choking and immediate use of established first-aid techniques.

With the FDA’s de novo authorization, LifeVac may now market the device in the United States within the framework established by the agency, potentially expanding access to this type of emergency airway-clearing tool.