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QXNClass II

Suction Anti-Choking Device As A Second-Line Treatment

21 CFR 874.5400 / Ear, Nose, Throat

QXN is the FDA product code for Suction Anti-Choking Device As A Second-Line Treatment, a class II device type, regulated under 21 CFR 874.5400. FDA's definition for this code 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 treatment in an emergency situation after unsuccessful use of a basic life support (BLS)...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QXN
Device name
Suction Anti-Choking Device As A Second-Line Treatment
FDA 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.
Regulation
21 CFR 874.5400
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QXN

By decision year
1 clearance under product code QXN with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXN by decision year
YearClearances
20261

Applicants with the most clearances

Product code QXN
Applicants holding the most 510(k) clearances under product code QXN
ApplicantClearances
LifeVac, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code