Cleared Traditional

K102605 - MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

K102605 is the FDA 510(k) clearance for MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER by Covidien, LLC, Formerly Registered AS Tyco Healthca. It is a Class 2 Gastroenterology & Urology device (product code NIE) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K102605 · Covidien, LLC, Formerly Registered AS Tyco Healthca · Gastroenterology & Urology device
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Dec 2010
Decision
103d
Days
Class 2
Risk

K102605 is an FDA 510(k) clearance for the MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Triple Lumen, Non-implanted (product code NIE), Class II - Special Controls.

Submitted by Covidien, LLC, Formerly Registered AS Tyco Healthca (Mansfield, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 103 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 Covidien, LLC, Formerly Registered AS Tyco Healthca devices

Submission Details

510(k) Number K102605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 10, 2010
Decision Date December 22, 2010
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NIE Catheter, Hemodialysis, Triple Lumen, Non-implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion.
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 - NIE Catheter, Hemodialysis, Triple Lumen, Non-implanted

All 9
Devices cleared under the same product code (NIE) and FDA review panel - the closest regulatory comparables to K102605.
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
K141531 · C.R. Bard, Inc. · Jun 2015
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
K133456 · C.R. Bard, Inc. · Sep 2014
T3
K123292 · Medcomp · Jun 2013
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675 · C.R. Bard, Inc. · Mar 2009
MEDCOMP T-3
K033570 · Medcomp · Sep 2004