Cleared Traditional

K192807 - Duo-Flow Side x Side Double Lumen Catheter

K192807 is an FDA 510(k) clearance for Duo-Flow Side x Side Double Lumen Catheter, manufactured by Medical Components, Inc. (dba MedComp). The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K192807 · Medical Components, Inc. (dba MedComp) · Gastroenterology & Urology device
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Apr 2020
Decision
205d
Days
Class 2
Risk

K192807 is an FDA 510(k) clearance for the Duo-Flow Side x Side Double Lumen Catheter. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on April 23, 2020 after a review of 205 days - an extended review cycle.

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 Medical Components, Inc. (dba MedComp) devices

FDA 510(k) Submission Details - K192807

510(k) Number K192807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2019
Decision Date April 23, 2020
Days to Decision 205 days
Submission Type Traditional
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
75d slower than avg
Panel avg: 130d · This submission: 205d
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 29
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K192807.
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
Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
K192302 · Covidien, LLC · Jan 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