Cleared Traditional

K102605 - MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

K102605 is an FDA 510(k) clearance for MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER, manufactured by Covidien, LLC, Formerly Registered AS Tyco Healthca. The device is a Class 2 Gastroenterology & Urology device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K102605

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
28d faster than avg
Panel avg: 131d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NIE Device Classification - Class 2, Special Controls

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 10
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