NESCONSET, NY: LifeVac LLC announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for LifeVac under 21 CFR 874.5400, formally establishing the device type “suction anti-choking device as a second-line treatment.”
Under the order, LifeVac is classified as a Class II medical device. The FDA defines this device type as one intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction, and to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol.
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 that Class II classification, together 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.”
As a result of the order, LifeVac may immediately market the device as described in the De Novo request, subject to the general and special controls outlined by FDA.
About LifeVac LLC:
LifeVac is a company known for its lifesaving airway clearance device of the same name. Founded in 2012, it is based out of Nesconset, New York. It is registered with MHRA, and Australia ARTG.