LifeVac received FDA authorization on March 4, 2026, making it the first and only anti-choking suction device cleared by the agency in the United States. The clearance is narrower than the company’s earlier marketing implied: the FDA authorized LifeVac only as a second-line treatment for adults and children at least one year old, to be used after standard choking rescue steps like back blows and abdominal thrusts have failed.1FDA. De Novo Classification Request DEN250012 The authorization also came with mandatory postmarket study requirements and followed roughly a decade of sales without any FDA premarket review.
What the FDA Actually Authorized
The clearance came through the De Novo pathway (DEN250012), which the FDA uses for novel, low-to-moderate risk devices. The agency classified the LifeVac Rescue Suction Device as a Class II “suction anti-choking device as a second-line treatment” under 21 CFR 874.5400.1FDA. De Novo Classification Request DEN250012
Second-line is the key phrase. The FDA has been explicit that people should not delay performing standard choking rescue techniques to retrieve or assemble the device, and that recognized choking rescue protocols from the American Red Cross and the American Heart Association do not include anti-choking devices.2FDA. Update: FDA Encourages Public to Follow Established Choking Rescue Protocols The authorization does not cover infants under one year old.
A Decade of Sales Without FDA Review
Arthur Lih developed the first LifeVac prototype in 2013 and started selling it in 2014.3LifeVac. About Us For about a decade, the device was distributed across the United States without going through any FDA premarket review. LifeVac had registered the product as Class II, but the agency later determined that was incorrect and told the company in April and May 2023 that the device was actually Class III and required a premarket submission.4FDA. Warning Letter to LifeVac LLC, MARCS-CMS 713455
The company did not comply. The FDA followed with formal directives to stop marketing the device on June 27, June 30, and August 4, 2025, and LifeVac was still selling the product as of September 17, 2025. The next day, the FDA’s Center for Devices and Radiological Health issued a formal warning letter to CEO Arthur Lih, stating that because LifeVac lacked an approved premarket application or an investigational device exemption, the product was “adulterated” under federal law. The agency demanded LifeVac stop marketing the device and warned that continued noncompliance could lead to product seizure, a court injunction, and civil money penalties.4FDA. Warning Letter to LifeVac LLC, MARCS-CMS 713455
The warning letter cited problems reported to the FDA about unauthorized anti-choking devices: failures to resolve choking due to inadequate suction, bruising around the face, lips, and mouth, and scratches to the back of the throat.2FDA. Update: FDA Encourages Public to Follow Established Choking Rescue Protocols Six months later, on March 4, 2026, the FDA closed out the warning letter alongside granting the De Novo classification, stating LifeVac had “addressed the violations.”5FDA. LifeVac LLC Close Out Letter
How Strong Is the Evidence That LifeVac Works
The scientific case is thin, and the FDA said so in the same document that authorized the device. In its De Novo review, the agency described the clinical data as coming from voluntary usage reports and a survey of 100,000 purchasers with a response rate of just 0.64%. The FDA characterized this data as having an “extreme limited sample size” with significant potential for reporting, selection, and recall bias. Among the six survey respondents who reported using the device exactly as instructed, five reported full or partial success, but the agency cautioned against drawing broad conclusions from that number.6FDA. De Novo Review Summary, DEN250012
Cadaver testing showed that 71% of attempts moved the obstruction toward the mouth, but success dropped significantly when the head was in a neutral position.6FDA. De Novo Review Summary, DEN250012 A 2020 systematic review published in Resuscitation found only five studies meeting its inclusion criteria for anti-choking suction devices, rated the certainty of evidence as “very low,” and concluded there was “insufficient evidence to support or discourage” use of these devices.7PubMed. A Systematic Review on the Effectiveness of Anti-Choking Suction Devices and Identification of Research Gaps A 2023 cadaver study cited by a Tampa Bay news outlet found the device failed to remove most foreign bodies and could cause “significant pressure and injury to the oral cavity.”8Tampa Bay 28. LifeVac Anti-Choking Device Used by Florida Police Departments Never Received FDA Approval The American Red Cross does not endorse the device.
The Death of an 11-Year-Old in Florida
On October 17, 2024, 11-year-old Benjamin Cronin choked during lunch at Laurel Oak Elementary School in Naples, Florida. An FDA adverse event report describes the child being found unconscious and not breathing. A nurse’s aide attempted to use a LifeVac and was quoted as saying, “he’s choking! It’s not working.” Multiple attempts to clear the obstruction, including the Heimlich maneuver and the LifeVac, were unsuccessful. The child died two days later.9FDA MAUDE Database. Adverse Event Report 3011053282-2025-00001
LifeVac filed the adverse event report but disputed how the incident was characterized. The company said it had not been contacted by the school, EMS, or the family and could not confirm whether an actual airway obstruction had occurred or whether the device had been used properly. LifeVac argued the child’s two-day survival was inconsistent with a fully obstructed airway and cited a secondhand report suggesting the boy may have been experiencing cardiac arrest rather than choking.9FDA MAUDE Database. Adverse Event Report 3011053282-2025-00001
Conditions Attached to the Authorization
The clearance is not a clean bill of health. Because the FDA found the premarket data too limited to fully characterize how LifeVac performs in real emergencies, the agency imposed mandatory postmarket surveillance. LifeVac must submit a study protocol within 30 days of the order and reach full enrollment within five years. The study has to track how often the device actually resolves choking, what adverse events occur, whether users call 911 and perform standard choking protocols first, and whether the device causes delays in starting life-saving maneuvers. If LifeVac misses enrollment milestones or reporting deadlines, the device could again be deemed adulterated or misbranded.6FDA. De Novo Review Summary, DEN250012
The FDA’s close-out letter stated that the resolution “does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance” and that future inspections would assess whether the corrections hold up.5FDA. LifeVac LLC Close Out Letter
A Separate FTC Matter Over “Made in USA” Claims
One boundary worth noting: the FTC’s investigation of LifeVac was about labeling, not safety or effectiveness. The commission alleged the company marketed products as “Made in the USA” despite significant imported content, in potential violation of the Made in USA Labeling Rule. LifeVac removed the claims from television and social media, and the FTC closed the matter on January 21, 2025 without further action, while reserving the right to reopen it. Civil penalties for violations can reach $53,088 each.10FTC. Closing Letter to LifeVac
What This Means If You Own or Are Considering One
LifeVac is now legally authorized to be sold in the United States, but the authorization defines a specific role. Standard choking rescue protocols come first: call for help, back blows, abdominal thrusts. The device is cleared only for what happens if those fail, and only for people at least one year old. The FDA itself has warned against delaying standard techniques to grab or set up the device. And the agency is requiring a multi-year study precisely because it does not yet know how often LifeVac works in real emergencies.