Cleared Traditional

K042672 - 14F DUAL FLOATING DIALYSIS CATHETER/TRAY

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

K042672 · Cardio Med Supplies, Inc. · Gastroenterology & Urology device
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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

FDA 510(k) Submission Details - K042672

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 131d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

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 106
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K042672.
MEDCOMP SPLIT CATH II
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HEMOCATH
K043292 · Med-Conduit, Inc. · Mar 2005
MEDCOMP SPLIT-CATH II
K040318 · Medcomp · Feb 2005
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
K043272 · Kendall · Dec 2004