Cleared Traditional

K130851 - CASCADE HEMODIALYSIS/APHERESIS CATHETER

K130851 is an FDA 510(k) clearance for CASCADE HEMODIALYSIS/APHERESIS CATHETER, manufactured by Health Line International Corporation. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K130851 · Health Line International Corporation · Gastroenterology & Urology device
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Jan 2014
Decision
288d
Days
Class 2
Risk

K130851 is an FDA 510(k) clearance for the CASCADE HEMODIALYSIS/APHERESIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Health Line International Corporation (Centerville, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 288 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 Health Line International Corporation devices

FDA 510(k) Submission Details - K130851

510(k) Number K130851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 27, 2013
Decision Date January 09, 2014
Days to Decision 288 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
157d slower than avg
Panel avg: 131d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, 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 - MSD Catheter, Hemodialysis, Implanted

All 122
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K130851.
SPLIT CATH RG
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K131260 · Navilyst Medical, Inc. · Feb 2014
NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),
K133796 · Marvao Medical Devices, Ltd. · Jan 2014
AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
K131814 · Ameco Medical Industries · Jul 2013
NEXTSTEP RETROGRADE
K130192 · Arrow International, Inc. · May 2013
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
K123943 · Ameco Medical Industries · Apr 2013