FDA cleared LifeVac as backup only after traditional methods fail
The Wall Street Journal reported Wednesday that LifeVac, the dominant U.S. maker of portable anti-choking devices, has donated more than 10,000 units to schools across the country. The company sells a four-device school kit that retails for nearly $280, with a 20 percent discount for schools. CEO Arthur Lih said he expects the company will bring in $70 million in revenue globally this year.
Texas enacted a law last year requiring school districts to stock at least one anti-choking device on each campus with at least one employee trained to use it. New York City passed a similar law. At least nine other states have weighed or are weighing bills to put the devices into schools or other facilities.
“It’s a priority,” said New Jersey state Sen. Kristin Corrado, who co-sponsored one bill. “If we have the opportunity to save a life, we have to use all means available.”
LifeVac is the sole suction-based anti-choking device authorized by the Food and Drug Administration. The agency gave it the green light in March as a second-line tool to be used only after traditional methods have failed. The device consists of a mask placed over a victim’s nose and mouth and a suction mechanism that creates negative pressure to pull out a stuck object. Lih told the Journal that inspiration for his design came from a sink plunger from Home Depot and suction devices in ambulances.
The American Heart Association and American Red Cross, which offer first-aid courses, do not recommend the devices in their choking guidelines.
“It might work, but we don’t know,” said Dr. Benny Joyner, a pediatrician and co-chair of the AHA’s pediatric basic life-support guidelines. Studies on the devices so far are too limited to base a recommendation on them, he said.
The American Red Cross said that while its scientific advisory council once discussed a potential recommendation, its guidance remains unchanged and anti-choking devices are not included in its courses or training programs.
Among those voicing concerns are the children of Dr. Henry Heimlich, the doctor who devised the abdominal-thrust technique more than 50 years ago. Phil Heimlich, a former prosecutor and former county commissioner in Cincinnati, said that in their marketing, makers of anti-choking devices tout their products but don’t emphasize that they are for use only as a second-line option.
“There’s massive amounts of money going to promote these devices,” he said. “If they were serious about informing people about how to save lives, they would put the Heimlich maneuver on top of their website.”
Lih said his company isn’t trying to supplant the Heimlich maneuver or back blows. “If someone’s choking, try and get them to cough, do the Heimlich, back blows, do it, do it, do it, do it,” he said. “If it doesn’t work, you got a backup.”
“We are promoting the heck out of the Heimlich. Everything we say is, use it after protocol,” Lih said. The device also offers a rescue option for people with disabilities or other conditions like obesity or pregnancy that make established methods “impossible or impractical,” he said.
The FDA warns that “using an anti-choking device before established protocols could delay critical life-saving action.” Some emergency-response experts have expressed concern that people will waste precious minutes grabbing an anti-choking device when they should be performing back blows, abdominal thrusts or CPR.
A person who is choking can lose consciousness and go into cardiac arrest within three to five minutes, the Journal reported.
Eight-year-old Nicholas Gray died in February after choking on a grape at school in Manvel, Texas. School staff, including a nurse, and emergency responders tried multiple techniques, including the Heimlich maneuver and a LifeVac device, as well as a defibrillator and CPR, according to his mother Kenzie Gray and reports of the incident reviewed by the Journal.
Gray believes teachers need hands-on training in the traditional techniques to rescue people from choking. In-person training became mandatory at the school only after her son’s death, she said.
“It was a very expensive price for me to pay in that my child is now in heaven,” she said.
The road to authorization was rocky. The FDA warned the company four times in 2025 to stop marketing and distributing its device prior to authorization, and then pointed out that it had not complied with those requests. When it authorized the device in March as a second-line treatment for adults and children over 1 year old, the FDA required LifeVac to conduct a study collecting data on device use, including adverse events, and further performance testing to show it works as intended.
A summary of LifeVac’s request to the FDA showed 961 cases of complete or partial success, 87 percent of the uses analyzed from the company’s database. The study also showed 53 serious adverse events related to choking from 2016 through 2025, including 15 deaths. The company said none of the deaths were related to its device. The FDA said the deaths don’t establish that the device caused or contributed to them.
Lih said scientific evidence shows the device is safe and effective, including 22 independent studies.
Dr. Cody Dunne, an emergency medicine physician and Ph.D. candidate at the University of Calgary who led one of the studies cited by LifeVac and has not taken funding from the company, said more studies are needed.
“Initial data is promising and there may be a role, but we just don’t have the clear data to tell us exactly where that role is,” Dunne said. Published research on anti-choking devices is based on case reports, mannequin studies and cadaver studies, none of which directly simulate a live human choking, he said.
Most important, Dunne said, “would be to make sure that every single teacher, every high-school student, every principal, every janitor knows basic CPR and basic life support because that’s the first line, and there’s no sense having the second-line therapy if everyone’s not comfortable doing the first line.”
New York City said it would not implement its law unless the devices are recommended in medical guidelines. State health departments, emergency responders and teachers unions have pushed back against proposals to require the devices in schools because medical guidelines have not endorsed them.
LifeVac promotes the device to police departments, families and as a baby-shower gift in social-media ads and through a national spokesperson — former Secretary of Housing and Urban Development Ben Carson, a retired pediatric neurosurgeon, the Journal reported. Lih said the company has reports of more than 6,500 lives saved with its device overall, and the device has been used to resolve 120 choking incidents in schools.