Not Cleared Direct

DEN250012 - LifeVac (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN250012 · Lifevac, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
327d
Days
Class 2
Risk

DEN250012 is an FDA 510(k) submission (not cleared) for the LifeVac. Classified as Suction Anti-choking Device As A Second-line Treatment within the QXN classification (a specialized ENT category for anti-choking and airway clearance devices), Class II - Special Controls.

Submitted by Lifevac, LLC (Nesconset, US). The FDA issued a Not Cleared (DENG) decision on March 4, 2026 after a review of 327 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5400 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 327 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Lifevac, LLC devices

Submission Details

510(k) Number DEN250012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 11, 2025
Decision Date March 04, 2026
Days to Decision 327 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 89d · This submission: 327d
Pathway characteristics

Device Classification

Product Code QXN Suction Anti-choking Device As A Second-line Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.5400
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.