510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250012Unknown

LifeVac

LifeVac, LLC, Nesconset NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN250012 is the FDA 510(k) clearance record for LifeVac, a class II device, cleared for Lifevac, LLC on under FDA product code QXN (Suction Anti-Choking Device As A Second-Line Treatment). FDA's definition for product code QXN reads: "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...". FDA records list one 510(k) clearance for Lifevac, LLC. As of , FDA records show no recalls naming DEN250012.

Clearance record

Decision date
Received
(327 days to decision)
Product code
QXN Suction Anti-Choking Device As A Second-Line Treatment
Regulation
21 CFR 874.5400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Lifevac, LLC 110 Lake Ave. S., Suite 35, Nesconset NY
Third party review
No

Clearances, product code QXN

Trailing 12 months
1 clearance under product code QXN in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QXN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260