Cleared Special

K243126 - TRACHEOBRONXANE™ DUMON® (FDA 510(k) Clearance)

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

K243126 · Novatech SA · Anesthesiology device
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Oct 2024
Decision
29d
Days
Class 2
Risk

K243126 is an FDA 510(k) clearance for the TRACHEOBRONXANE™ DUMON®. Classified as Prosthesis, Tracheal, Preformed/molded (product code NWA), Class II - Special Controls.

Submitted by Novatech SA (La Ciotat Cedex, FR). The FDA issued a Cleared decision on October 29, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 878.3720 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Novatech SA devices

Submission Details

510(k) Number K243126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date October 29, 2024
Days to Decision 29 days
Submission Type Special
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
110d faster than avg
Panel avg: 139d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NWA Prosthesis, Tracheal, Preformed/molded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
Definition The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.
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.