Cleared Traditional

K041987 - CORTRAK

K041987 is an FDA 510(k) clearance for CORTRAK, manufactured by Viasys Medsystems. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K041987 · Viasys Medsystems · Gastroenterology & Urology device
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Dec 2004
Decision
147d
Days
Class 2
Risk

K041987 is an FDA 510(k) clearance for the CORTRAK. 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 December 17, 2004 after a review of 147 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K041987

510(k) Number K041987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date December 17, 2004
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

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 389
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K041987.
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K051551 · Olympus Medical Systems Corporation · Jun 2005
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K043203 · Wilson-Cook Medical, Inc. · May 2005
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
K043258 · Teleflex Medical · Dec 2004
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
K043114 · Kimberly-Clark Corp. · Dec 2004
MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
K043027 · Applied Medical Technology, Inc. · Dec 2004