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 Corp, Boston Scientific Corporation and Micro-Tech (Nanjing) Co., Ltd..

45
Total
45
Cleared
135d
Avg days
1991
Since
Declining activity - 0 submissions in the last 2 years vs 2 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 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 Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100
Boston Scientific Corp
General & Plastic Surgery · 78d
Cleared Nov 18, 1999
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K992510
Boston Scientific Corp
General & Plastic Surgery · 114d
Cleared Nov 14, 1996
ULTRAFLEX
K963241
Boston Scientific Corp
General & Plastic Surgery · 87d

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 2 in the prior period.