Cleared Special

K120674 - MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER

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

K120674 · Covidien · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K120674

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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MPB Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K120674.
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
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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
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
K110793 · Ameco Medical Industries · Dec 2011
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
K102833 · Foshan Nanhai Bai HE Medical Technology Co., Ltd. · Nov 2011
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A
K100451 · Gambro Renal Products, Inc. · Dec 2010
K120674 · MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
Download PDF FDA Summary Covidien