Cleared Traditional

K121048 - ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM...

K121048 is the FDA 510(k) clearance for ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM... by Boston Scientific Corp. It is a Class 2 General & Plastic Surgery device (product code JCT) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K121048 · Boston Scientific Corp · General & Plastic Surgery device
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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
Combination Product No
PCCP Authorized No
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 18
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K121048.
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
K152842 · Boston Scientific Corporation · May 2016
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
K140382 · Merit Medical Systems, Inc. · Nov 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · Boston Scientific Corporation · Oct 2014
ATRIUM ICAST COVERED STENT
K050814 · Atrium Medical Corp. · May 2005
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K041269 · Atrium Medical Corp. · Sep 2004
VIATORR ENDOPROSTHESIS
K024178 · W.L. Gore & Associates, Inc. · Mar 2003