Cleared Traditional

CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (K063061) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063061 · Viasys Medsystems · Gastroenterology & Urology device
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Apr 2007
Decision
179d
Days
Class 2
Risk

K063061 is an FDA 510(k) clearance for the CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Viasys Medsystems (Wheeling, US). The FDA issued a Cleared decision on April 2, 2007 after a review of 179 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Viasys Medsystems devices

Submission Details

510(k) Number K063061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2006
Decision Date April 02, 2007
Days to Decision 179 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 130d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 165
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K063061.
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K072476 · Boston Scientific Corporation · Dec 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007
ENTAKE STANDARD AND SAFETY PEG SYSTEM
K061021 · Conmedcorp · Apr 2006
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551 · Olympus Medical Systems Corporation · Jun 2005