LifeVac has announced that the US FDA has granted De Novo classification for its LifeVac device, officially recognizing the device as a “suction anti-choking device as a second-line treatment.”

 

The FDA classified LifeVac as a Class II medical device, defining it as a tool intended to resolve complete airway obstructions through suction, to be used only after basic life support (BLS) choking protocols have failed.

 

The clearance confirms that LifeVac is a non-powered, non-invasive, single-use airway clearance device suitable for both adult and pediatric choking victims aged one and up. The device can be administered by laypersons or medical professionals in homes, schools, restaurants, nursing homes, and other settings.

 

FDA officials determined that the Class II designation, along with general and special controls, “provides reasonable assurance of the safety and effectiveness of the device for its intended use.”

 

“As stated in the order, LifeVac is intended to be used after a BLS choking protocol fails,” said Arthur Lih, Founder and CEO of LifeVac. “This classification creates a clear regulatory framework for suction anti-choking devices used as a second-line treatment.”

 

With the De Novo order in place, LifeVac can immediately market the device according to its approved indications, subject to FDA-mandated controls.