Cleared Traditional

K002255 - LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)

K002255 is an FDA 510(k) clearance for LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DE..., manufactured by Wolfe Tory Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CCT cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K002255 · Wolfe Tory Medical, Inc. · Anesthesiology device
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Sep 2000
Decision
55d
Days
Class 2
Risk

K002255 is an FDA 510(k) clearance for the LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC). Classified as Applicator (laryngo-tracheal), Topical Anesthesia (product code CCT), Class II - Special Controls.

Submitted by Wolfe Tory Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 18, 2000 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5170 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wolfe Tory Medical, Inc. devices

FDA 510(k) Submission Details - K002255

510(k) Number K002255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2000
Decision Date September 18, 2000
Days to Decision 55 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 140d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCT Device Classification - Class 2, Special Controls

Product Code CCT Applicator (laryngo-tracheal), Topical Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5170
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.

Regulatory Peers - CCT Applicator (laryngo-tracheal), Topical Anesthesia

Devices cleared under the same product code (CCT) and FDA review panel - the closest regulatory comparables to K002255.
UltraEzAir® (UEA1A)
K240114 · Dualams, Inc., Dba Airkor · Oct 2024
Medicant Mucosal Atomizer
K172956 · Medica Holdings, LLC · Apr 2018
MADgic Laryngo-Tracheal Mucosal Atomization Device
K153470 · Teleflex Medical · Aug 2016
ENDO-MED TUBE FOR ENDOTRACHEAL MED
K810059 · Ackrad Laboratories · Feb 1981
ANESTHESIA KIT
K760759 · Sherwood Medical Industries · Dec 1976
MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT
K760877 · Sherwood Medical Industries · Dec 1976