Cleared Traditional

K040992 - 15F X 55CM EXCELL SPLIT -TIP CATHETER

K040992 is the FDA 510(k) clearance for 15F X 55CM EXCELL SPLIT -TIP CATHETER by Medcomp. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K040992 · Medcomp · Gastroenterology & Urology device
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Jul 2004
Decision
104d
Days
Class 2
Risk

K040992 is an FDA 510(k) clearance for the 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on July 29, 2004 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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.

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Submission Details

510(k) Number K040992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 16, 2004
Decision Date July 29, 2004
Days to Decision 104 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 130d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MSD Catheter, Hemodialysis, Implanted

All 42
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K040402 · AngioDynamics, Inc. · Apr 2004
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K040492 · Boston Scientific Corp · Mar 2004