Cleared Traditional

K051280 - MEDCOMP SPLIT CATH II

K051280 is the FDA 510(k) clearance for MEDCOMP SPLIT CATH II by Medcomp. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K051280 · Medcomp · Gastroenterology & Urology device
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Nov 2005
Decision
197d
Days
Class 2
Risk

K051280 is an FDA 510(k) clearance for the MEDCOMP SPLIT CATH II. 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 30, 2005 after a review of 197 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.

View all Medcomp devices

Submission Details

510(k) Number K051280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date November 30, 2005
Days to Decision 197 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
67d slower than avg
Panel avg: 130d · This submission: 197d
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 K051280.
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148 · Merit Medical Systems, Inc. · Apr 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101 · C.R. Bard, Inc. · Feb 2009
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
K080400 · AngioDynamics, Inc. · May 2008
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
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