LifeVac has picked up a groundbreaking clearance from the FDA for its suction-powered device designed to dislodge an object blocking a person’s airway, for use when other choking rescue protocols such as the Heimlich maneuver have failed.
The single-use, hand-operated device—with a plunger and air mask placed over the nose and mouth—is designed for adults and children at least 1 year old. It can be used by medical professionals and members of the general public.
The FDA granted the de novo green light last week after previously warning the public that these types of devices should not be used ahead of the steps recommended by groups such as the American Red Cross and the American Heart Association, including back blows and abdominal thrusts. It said foregoing those actions while unwrapping and readying the device could delay critical actions that have shown high success rates.
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The agency had also issued a warning letter to LifeVac last September—followed shortly by an import alert to multiple manufacturers of unreviewed products—saying the company had been marketing its device as lifesaving equipment without a proper authorization. LifeVacs have been available over-the-counter and supplied to police departments, EMTs and other first responders. The FDA said it closed out LifeVac’s warning letter March 4, alongside the de novo clearance.
“As stated in the order, LifeVac is intended to be used after a [basic life support] choking protocol fails,” said Arthur Lih, CEO of the Long Island, New York-based company. “This classification creates a clear regulatory framework for suction anti-choking devices used as a second-line treatment.”
In late 2024, the company claimed it had logged nearly 3,000 lives saved with its approach, alongside an announcement that the American Red Cross’ scientific advisors had begun considering the use of suction-powered anti-choking devices, while still recommending that back blows and abdominal thrusts remain the standard while a person is conscious.
In January, Lih told the New York Post that the company has now counted more than 5,000 lives saved and expects LifeVac to reach 10,000 by the end of the year.
