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FDA PRODUCT CODE · CLASS II

QXN — Suction Anti-Choking Device As A Second-Line Treatment

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 874.5400
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
EN
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

DEN250012Lifevac, LLC · 510k2026-03-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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