Cleared Traditional

K140382 - AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY

K140382 is an FDA 510(k) clearance for AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCT cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K140382 · Merit Medical Systems, Inc. · General & Plastic Surgery device
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Nov 2014
Decision
284d
Days
Class 2
Risk

K140382 is an FDA 510(k) clearance for the AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 25, 2014 after a review of 284 days - an extended review cycle.

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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K140382

510(k) Number K140382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date November 25, 2014
Days to Decision 284 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 115d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCT Device Classification - Class 2, Special Controls

Product Code JCT Prosthesis, Tracheal, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
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.

Regulatory Peers - JCT Prosthesis, Tracheal, Expandable

All 29
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K140382.
HANAROSTENT Trachea/Bronchium (CCC)
K201342 · M.I. Tech Co., Ltd. · Dec 2020
AEROmini Tracheobronchial Stent System
K181200 · Merit Medical Systems, Inc. · Sep 2018
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
K152842 · Boston Scientific Corporation · May 2016
BONASTENT TRACHEAL / BRONCHIAL
K140472 · Endochoice, Inc. · Oct 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · Boston Scientific Corporation · Oct 2014
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048 · Boston Scientific Corp · Aug 2012