Cleared Traditional

K153470 - MADgic Laryngo-Tracheal Mucosal Atomiza...

K153470 is an FDA 510(k) clearance for MADgic Laryngo-Tracheal Mucosal Atomiza..., manufactured by Teleflex Medical. The device is a Class 2 Anesthesiology device with product code CCT cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K153470 · Teleflex Medical · Anesthesiology device
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Aug 2016
Decision
261d
Days
Class 2
Risk

K153470 is an FDA 510(k) clearance for the MADgic Laryngo-Tracheal Mucosal Atomization Device. Classified as Applicator (laryngo-tracheal), Topical Anesthesia (product code CCT), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 19, 2016 after a review of 261 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflex Medical devices

FDA 510(k) Submission Details - K153470

510(k) Number K153470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2015
Decision Date August 19, 2016
Days to Decision 261 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 140d · This submission: 261d
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 K153470.
UltraEzAir® (UEA1A)
K240114 · Dualams, Inc., Dba Airkor · Oct 2024
Medicant Mucosal Atomizer
K172956 · Medica Holdings, LLC · Apr 2018
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