Cleared Special

K230269 - Ultraflex™ Tracheobronchial Stent System

K230269 is an FDA 510(k) clearance for Ultraflex Tracheobronchial Stent System, manufactured by Boston Scientific Corporation. The device is a Class 2 Anesthesiology device with product code JCT cleared through the Special 510(k) pathway after a 164-day FDA review.

K230269 · Boston Scientific Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
164d
Days
Class 2
Risk

K230269 is an FDA 510(k) clearance for the Ultraflex™ Tracheobronchial Stent System. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on July 14, 2023 after a review of 164 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 878.3720 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K230269

510(k) Number K230269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2023
Decision Date July 14, 2023
Days to Decision 164 days
Submission Type Special
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
24d slower than avg
Panel avg: 140d · This submission: 164d
Pathway characteristics
Modification to existing cleared device.

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 44
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K230269.
Through the Scope Tracheal Stent System
K220424 · Micro-Tech (Nanjing) Co., Ltd. · Jul 2022
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
AEROmini Tracheobronchial Stent System
K181200 · Merit Medical Systems, Inc. · Sep 2018
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
K152842 · Boston Scientific Corporation · May 2016
K230269 · Ultraflex™ Tracheobronchial Stent System
Download PDF FDA Summary Boston Scientific Cor…