Cleared Special

ATRIUM ICAST COVERED STENT (K050814) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050814 · Atrium Medical Corp. · General & Plastic Surgery device
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May 2005
Decision
36d
Days
Class 2
Risk

K050814 is an FDA 510(k) clearance for the ATRIUM ICAST COVERED STENT. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on May 6, 2005 after a review of 36 days - a notably fast clearance cycle.

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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atrium Medical Corp. devices

Submission Details

510(k) Number K050814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date May 06, 2005
Days to Decision 36 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 17
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K050814.
AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
K140382 · Merit Medical Systems, Inc. · Nov 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
K141584 · Boston Scientific Corporation · Oct 2014
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048 · Boston Scientific Corp · Aug 2012
VIATORR ENDOPROSTHESIS
K024178 · W.L. Gore & Associates, Inc. · Mar 2003
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K023811 · W.L. Gore & Associates, Inc. · Dec 2002
VIABAHN ENDOPROSTHESIS
K013648 · W.L. Gore & Associates, Inc. · Jan 2002