FDA De Novo Classification Granted for Anti-Choking Device

LifeVac LLC has secured U.S. Food and Drug Administration (FDA) De Novo classification for LifeVac, formally establishing the “suction anti-choking device as a second-line treatment.”

Under the De Novo order, LifeVac is classified as a Class II medical device. According to the FDA’s definition, the product uses suction to resolve choking in victims experiencing complete airway obstruction, and is intended as a second-line treatment in an emergency situation once basic life support (BLS) choking protocol fails.

The cleared indications state that LifeVac is a non-powered, non-invasive, single-use-only airway clearance device intended for adult and pediatric choking victims (at least 1 year of age), and may be administered by a lay person or medical professional (18 years or older) in settings including homes, nursing homes, restaurants, and schools.

FDA determined the Class II classification, 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,” LifeVac Founder/CEO Arthur Lih stated. “This classification creates a clear regulatory framework for suction anti-choking devices used as a second-line treatment.”

The order allows LifeVac to immediately market the device.

LifeVac is a company known for its lifesaving airway clearance device of the same name. Founded in 2012, it is based out of Nesconset, N.Y. It is registered with MHRA, and Australia’s ARTG.