Cleared Traditional

K040328 - 15.5F JET MEDICAL FREE FLOW LONG-TERM C...

K040328 is the FDA 510(k) clearance for 15.5F JET MEDICAL FREE FLOW LONG-TERM C... by Medcomp. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K040328 · Medcomp · Gastroenterology & Urology device
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Nov 2004
Decision
288d
Days
Class 2
Risk

K040328 is an FDA 510(k) clearance for the 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 288 days - an extended review cycle.

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 K040328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2004
Decision Date November 24, 2004
Days to Decision 288 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
158d slower than avg
Panel avg: 130d · This submission: 288d
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
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K040328.
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K051748 · C.R. Bard, Inc. · Aug 2005
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016 · Datascope Corp. · Sep 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736 · Boston Scientific Corp · May 2004
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
K040402 · AngioDynamics, Inc. · Apr 2004