JCT · Class II · 21 CFR 878.3720

FDA Product Code JCT: Prosthesis, Tracheal, Expandable

Tracheal reconstruction requires durable, biocompatible implants. FDA product code JCT covers expandable tracheal prostheses placed to restore airway patency.

These self-expanding stents or structured prostheses are deployed endoscopically or surgically to maintain an open tracheal lumen in patients with tracheal stenosis caused by prolonged intubation, trauma, tumors, or tracheomalacia.

JCT devices are Class II medical devices, regulated under 21 CFR 878.3720 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Boston Scientific Scimed, Inc., Alveolus, Inc. and Boston Scientific Corp.

45
Total
45
Cleared
135d
Avg days
1991
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prosthesis, Tracheal, Expandable Devices (Product Code JCT)

45 devices
1–24 of 45
Cleared Jul 14, 2023
Ultraflex™ Tracheobronchial Stent System
K230269
Boston Scientific Corporation
Anesthesiology · 164d
Cleared Jul 08, 2022
Through the Scope Tracheal Stent System
K220424
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 144d
Cleared Oct 30, 2021
Tracheal Stent System (Y-Shaped)
K212403
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 89d
Cleared Sep 01, 2021
Tracheal Stent System
K202204
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 392d
Cleared Dec 31, 2020
HANAROSTENT Trachea/Bronchium (CCC)
K201342
M.I. Tech Co., Ltd.
Anesthesiology · 225d
Cleared Sep 21, 2018
AEROmini Tracheobronchial Stent System
K181200
Merit Medical Systems, Inc.
Anesthesiology · 137d
Cleared May 19, 2016
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
K152842
Boston Scientific Corporation
General & Plastic Surgery · 233d
Cleared Nov 25, 2014
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
K140382
Merit Medical Systems, Inc.
General & Plastic Surgery · 284d
Cleared Oct 17, 2014
BONASTENT TRACHEAL / BRONCHIAL
K140472
Endochoice, Inc.
Anesthesiology · 234d
Cleared Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584
Boston Scientific Corporation
General & Plastic Surgery · 125d
Cleared Aug 03, 2012
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048
Boston Scientific Corp
General & Plastic Surgery · 119d
Cleared Mar 11, 2009
AERO DV TRACHEOBRONCHIAL STENT SYSTEM
K083625
Alveolus, Inc.
General & Plastic Surgery · 93d
Cleared Nov 20, 2008
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
K082284
Alveolus, Inc.
General & Plastic Surgery · 101d
Cleared Sep 19, 2007
ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
K071604
Alveolus, Inc.
General & Plastic Surgery · 99d
Cleared Jan 31, 2007
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
K062511
Alveolus, Inc.
General & Plastic Surgery · 156d
Cleared Jul 07, 2005
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
K050832
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 97d
Cleared May 06, 2005
ATRIUM ICAST COVERED STENT
K050814
Atrium Medical Corp.
General & Plastic Surgery · 36d
Cleared Sep 14, 2004
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K041269
Atrium Medical Corp.
General & Plastic Surgery · 125d
Cleared May 12, 2004
ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K033990
Alveolus, Inc.
General & Plastic Surgery · 141d
Cleared Feb 25, 2004
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K033053
Alveolus, Inc.
General & Plastic Surgery · 149d
Cleared Nov 13, 2003
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K032744
Alveolus, Inc.
General & Plastic Surgery · 70d
Cleared Aug 01, 2003
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
K031641
Vascular Architects, Inc.
General & Plastic Surgery · 66d
Cleared Jun 19, 2003
FLUENCY TRACHEOBRONCHIAL STENT GRAFT
K031041
Bard Peripheral Vascular
General & Plastic Surgery · 79d
Cleared May 15, 2003
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K030947
Alveolus, Inc.
General & Plastic Surgery · 50d

About Product Code JCT - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code JCT since 1991, with 45 receiving FDA clearance (average review time: 135 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.