Cleared Special

K120674 - MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER

K120674 is the FDA 510(k) clearance for MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER by Covidien. It is a Class 2 Gastroenterology & Urology device (product code MPB) cleared through the Special 510(k) pathway after a 30-day FDA review.

K120674 · Covidien · Gastroenterology & Urology device
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Apr 2012
Decision
30d
Days
Class 2
Risk

K120674 is an FDA 510(k) clearance for the MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on April 4, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Covidien devices

Submission Details

510(k) Number K120674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 05, 2012
Decision Date April 04, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MPB Catheter, Hemodialysis, Non-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 - MPB Catheter, Hemodialysis, Non-implanted

All 26
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K120674.
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COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
K122091 · Cook, Inc. · Jul 2013
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
K090102 · C.R. Bard, Inc. · Feb 2009
NIAGARA TEMPORARY DUAL LUMEN CATHETERS
K030268 · C.R. Bard, Inc. · Jul 2003
NIAGARA SLIM-CATH
K010778 · C.R. Bard, Inc. · Apr 2001