DeviceClearance

Product code QXN— Ear, Nose, Throat

LifeVac

Classification name
Suction Anti-Choking Device As A Second-Line Treatment
Device class
Class 2
Regulation
21 CFR 874.5400
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

FDA classification definition

“A suction anti-choking device as a second-line treatment is intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction. The device is intended to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol.”

— U.S. Food and Drug Administration, device classification record for product code QXN under 21 CFR 874.5400, via openFDA

Market context for product code QXN

FDA has cleared 1 device under product code QXN, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QXN

Recent clearances under product code QXN

Data sourced from openFDA. This site is unofficial and independent of the FDA.