Cleared Traditional

K200426 - Acute Dual Lumen Hemodialysis Catheter (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200426 · Health Line International Corporation · Gastroenterology & Urology device
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Dec 2020
Decision
307d
Days
Class 2
Risk

K200426 is an FDA 510(k) clearance for the Acute Dual Lumen Hemodialysis Catheter. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on December 24, 2020 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Health Line International Corporation devices

Submission Details

510(k) Number K200426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 21, 2020
Decision Date December 24, 2020
Days to Decision 307 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
177d slower than avg
Panel avg: 130d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 37
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K200426.
14F Duo-Flow® Side X Side Double Lumen Catheter
K250836 · Medical Components, Inc. · Aug 2025
Duo-Flow Side x Side Double Lumen Catheter
K192807 · Medical Components, Inc. (dba MedComp) · Apr 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