Cleared Traditional

K083625 - AERO DV TRACHEOBRONCHIAL STENT SYSTEM

K083625 is an FDA 510(k) clearance for AERO DV TRACHEOBRONCHIAL STENT SYSTEM, manufactured by Alveolus, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCT cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K083625 · Alveolus, Inc. · General & Plastic Surgery device
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Mar 2009
Decision
93d
Days
Class 2
Risk

K083625 is an FDA 510(k) clearance for the AERO DV TRACHEOBRONCHIAL STENT SYSTEM. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Alveolus, Inc. (Charlotte, US). The FDA issued a Cleared decision on March 11, 2009 after a review of 93 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 Alveolus, Inc. devices

FDA 510(k) Submission Details - K083625

510(k) Number K083625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 08, 2008
Decision Date March 11, 2009
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCT Prosthesis, Tracheal, Expandable

All 30
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K083625.
BONASTENT TRACHEAL / BRONCHIAL
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K141584 · Boston Scientific Corporation · Oct 2014
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048 · Boston Scientific Corp · Aug 2012
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
K050832 · Bard Peripheral Vascular, Inc. · Jul 2005
ATRIUM ICAST COVERED STENT
K050814 · Atrium Medical Corp. · May 2005
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
K041269 · Atrium Medical Corp. · Sep 2004