Cleared Traditional

K042672 - 14F DUAL FLOATING DIALYSIS CATHETER/TRAY

K042672 is the FDA 510(k) clearance for 14F DUAL FLOATING DIALYSIS CATHETER/TRAY by Cardio Med Supplies, Inc.. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K042672 · Cardio Med Supplies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
175d
Days
Class 2
Risk

K042672 is an FDA 510(k) clearance for the 14F DUAL FLOATING DIALYSIS CATHETER/TRAY. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Cardio Med Supplies, Inc. (Gormley, Ontario, CA). The FDA issued a Cleared decision on March 23, 2005 after a review of 175 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 Cardio Med Supplies, Inc. devices

Submission Details

510(k) Number K042672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2004
Decision Date March 23, 2005
Days to Decision 175 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
45d slower than avg
Panel avg: 130d · This submission: 175d
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 64
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K042672.
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
K080400 · AngioDynamics, Inc. · May 2008
MEDCOMP SPLIT CATH II
K051280 · Medcomp · Nov 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748 · C.R. Bard, Inc. · Aug 2005
MEDCOMP SPLIT-CATH II
K040318 · Medcomp · Feb 2005
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
K040328 · Medcomp · Nov 2004
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
K042016 · Datascope Corp. · Sep 2004