Cleared Traditional

ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED (K121048) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121048 · Boston Scientific Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
119d
Days
Class 2
Risk

K121048 is an FDA 510(k) clearance for the ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on August 3, 2012 after a review of 119 days - within the typical 510(k) review window.

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 Boston Scientific Corp devices

Submission Details

510(k) Number K121048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2012
Decision Date August 03, 2012
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 44
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K121048.
Ultraflex™ Tracheobronchial Stent System
K230269 · Boston Scientific Corporation · Jul 2023
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