Cleared Traditional

DUMON TRACHEOBRONCHIAL STENT (K894380) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894380 · Bryan Corp. · General & Plastic Surgery device
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Oct 1989
Decision
99d
Days
Class 2
Risk

K894380 is an FDA 510(k) clearance for the DUMON TRACHEOBRONCHIAL STENT. Classified as Prosthesis, Tracheal, Preformed/molded (product code NWA), Class II - Special Controls.

Submitted by Bryan Corp. (Woburn, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3720 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bryan Corp. devices

Submission Details

510(k) Number K894380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date October 24, 1989
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General & Plastic Surgery devices follow this clearance model.