Cleared Traditional

K192302 - Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter

K192302 is an FDA 510(k) clearance for Mahurkar Acute Single Lumen Catheter, manufactured by Covidien, LLC. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K192302 · Covidien, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jan 2020
Decision
147d
Days
Class 2
Risk

K192302 is an FDA 510(k) clearance for the Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mah.... Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on January 17, 2020 after a review of 147 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 devices

FDA 510(k) Submission Details - K192302

510(k) Number K192302 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 23, 2019
Decision Date January 17, 2020
Days to Decision 147 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 131d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 35
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K192302.
14F Duo-Flow® Side X Side Double Lumen Catheter
K250836 · Medical Components, Inc. · Aug 2025
Acute Dual Lumen Hemodialysis Catheter
K200426 · Health Line International Corporation · Dec 2020
Duo-Flow Side x Side Double Lumen Catheter
K192807 · Medical Components, Inc. (dba MedComp) · Apr 2020
Zenysis Short-Term Dialysis Catheter
K163458 · C.R. Bard, Inc. · Apr 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
K161504 · Cook Incorporated · Jan 2017
Zenysis Short-Term Dialysis Catheter
K153190 · C.R. Bard, Inc. · Jan 2016