Cleared Traditional

K020465 - MEDCOMP ASH SPLIT-CATH II

K020465 is the FDA 510(k) clearance for MEDCOMP ASH 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 99-day FDA review.

K020465 · Medcomp · Gastroenterology & Urology device
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May 2002
Decision
99d
Days
Class 2
Risk

K020465 is an FDA 510(k) clearance for the MEDCOMP ASH 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 May 22, 2002 after a review of 99 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.

View all Medcomp devices

Submission Details

510(k) Number K020465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2002
Decision Date May 22, 2002
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
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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K012365 · Boston Scientific Corp · Aug 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567 · C.R. Bard, Inc. · Mar 2001
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · Boston Scientific Corp · Jul 1999