Cleared Traditional

K181200 - AEROmini Tracheobronchial Stent System

K181200 is an FDA 510(k) clearance for AEROmini Tracheobronchial Stent System, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code JCT cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K181200 · Merit Medical Systems, Inc. · Anesthesiology device
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Sep 2018
Decision
137d
Days
Class 2
Risk

K181200 is an FDA 510(k) clearance for the AEROmini Tracheobronchial Stent System. 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 September 21, 2018 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 878.3720 - 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 Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K181200

510(k) Number K181200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2018
Decision Date September 21, 2018
Days to Decision 137 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
3d faster than avg
Panel avg: 140d · This submission: 137d
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 Anesthesiology 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 K181200.
Tracheal Stent System (Y-Shaped)
K212403 · Micro-Tech (Nanjing) Co., Ltd. · Oct 2021
Tracheal Stent System
K202204 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2021
HANAROSTENT Trachea/Bronchium (CCC)
K201342 · M.I. Tech Co., Ltd. · Dec 2020
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
K152842 · Boston Scientific Corporation · May 2016
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
K140382 · Merit Medical Systems, Inc. · Nov 2014
BONASTENT TRACHEAL / BRONCHIAL
K140472 · Endochoice, Inc. · Oct 2014