LifeVac LLC has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification to its anti-choking device, LifeVac, formally establishing a new medical device category for suction-based airway clearance systems.

Under the FDA’s decision, the device has been classified under regulation 21 CFR 874.5400 as a ‘suction anti-choking device used as a second-line treatment.’ The product has been designated a Class II medical device, a category that includes devices requiring additional regulatory controls to ensure safety and effectiveness.

The FDA defines this device type as one designed to resolve choking caused by complete airway obstruction through the application of suction. The device is intended to be used in emergency situations only after standard basic life support choking procedures have been attempted and proven unsuccessful.

According to the cleared indications, LifeVac is a non-powered, non-invasive and single-use airway clearance device designed for both adult and pediatric choking victims aged one year and older. The device can be administered by either trained medical professionals or laypersons aged 18 and above.

The FDA noted that the device can be used in a wide range of settings including homes, nursing homes, restaurants and schools, providing an additional emergency intervention option when standard choking response methods fail.

The agency concluded that the Class II classification, combined with established general and special regulatory controls, provides reasonable assurance of the device’s safety and effectiveness for its intended use.

Arthur Lih, Founder and Chief Executive Officer, LifeVac LLC, said the regulatory decision establishes a clear framework for suction-based anti-choking devices designed to be used as a secondary intervention during choking emergencies.

Following the De Novo classification, LifeVac LLC is now authorised to market the device in the United States according to the specifications outlined in the FDA submission, subject to the regulatory requirements defined by the agency.