Cleared Traditional

K091637 - CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

K091637 is an FDA 510(k) clearance for CORTRAK ENTERAL ACCESS DEVICE, manufactured by Corpak Medsystems. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K091637 · Corpak Medsystems · Gastroenterology & Urology device
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Sep 2009
Decision
117d
Days
Class 2
Risk

K091637 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 Corpak Medsystems (Wheeling, US). The FDA issued a Cleared decision on September 29, 2009 after a review of 117 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 Corpak Medsystems devices

FDA 510(k) Submission Details - K091637

510(k) Number K091637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2009
Decision Date September 29, 2009
Days to Decision 117 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
14d faster than avg
Panel avg: 131d · This submission: 117d
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 486
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K091637.
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