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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

LifeVac, LLC

Issued · Posted by FDA

FDA published a close-out letter on Mar 4, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The LifeVac Rescue Suction Device is a Class III device under section 513(f)(1) of the Act, 21 U.S.C. § 360c(f)(1). This device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the device as described and marketed.