Not Cleared Post-NSE

DEN000004 - QUICKAIR CHOKE RELIEVER, MODEL 59-001A (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN000004 · Maet Industries, Inc. · Anesthesiology device
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Feb 2000
Decision
32d
Days
Class 2
Risk

DEN000004 is an FDA 510(k) submission (not cleared) for the QUICKAIR CHOKE RELIEVER, MODEL 59-001A. Classified as Device, Heimlich Maneuver Assist (product code MZT), Class II - Special Controls.

Submitted by Maet Industries, Inc. (Mississauga, Ontario, CA). The FDA issued a Not Cleared (DENG) decision on February 29, 2000 after a review of 32 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5115 - the FDA anesthesiology and respiratory 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Anesthesiology review framework.

View all Maet Industries, Inc. devices

Submission Details

510(k) Number DEN000004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 28, 2000
Decision Date February 29, 2000
Days to Decision 32 days
Submission Type Post-NSE
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 139d · This submission: 32d
Pathway characteristics

Device Classification

Product Code MZT Device, Heimlich Maneuver Assist
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5115
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 Anesthesiology devices follow this clearance model.