> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# LifeVac Marketing Illegal Airway Device: FDA
- URL: https://www.fdaweb.com/lifevac-marketing-illegal-airway-device-fda/
- Published: 2025-10-14T12:00:00.000Z
- Updated: 2026-09-14T15:24:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160034

FDA says it is aware that LifeVac, LLC, in Nesconset, NY, is illegally marketing its LifeVac Rescue Suction device since the device does not have agency marketing authorization. A just-released 9/18 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lifevac-llc-713455-09182025?ref=fdaweb.com) says the airway clearance device is used for resuscitating a victim with an airway obstruction when current choking protocols have been followed without success.

The letter says the agency’s review of the company’s Web site and marketing materials determined that the LifeVac Rescue Suction device is Class 3 and is adulterated because LifeVac does not have an approved PMA or IDE in effect.

FDA references 2023 and 2025 communications with the company, indicating the classification of the device and the need for a premarket submission. It also told the firm that the agency expects it to cease marketing and distributing the unauthorized device. “Your firm acknowledged receipt of these communications, but you continue to market and distribute the LifeVac Rescue Suction device as of 9/17,” the letter says.

The letter says FDA is concerned that LifeVac’s continued unauthorized marketing and distribution of its device may put the public health and safety at risk. It raises a 4/2024 Safety Communication that noted the safety and effectiveness of unauthorized anti-choking devices being sold over the counter have not been established. The communication also cited reported problems with such devices, including failure to resolve a choking incident due to a lack of suction; bruising around the face, lips, and mouth; and scratches in the back of the throat.

The letter tells LifeVac to act promptly to address the violation and to respond with a list of specific steps it has taken to address the violation and prevent its recurrence, with documentation of the corrections, and a schedule for completing them.