Cleared Traditional

K071422 - 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET

K071422 is an FDA 510(k) clearance for 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET, manufactured by Rex Medical. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K071422 · Rex Medical · Gastroenterology & Urology device
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Aug 2007
Decision
92d
Days
Class 2
Risk

K071422 is an FDA 510(k) clearance for the 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Rex Medical (Great Neck, US). The FDA issued a Cleared decision on August 22, 2007 after a review of 92 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 Rex Medical devices

FDA 510(k) Submission Details - K071422

510(k) Number K071422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 22, 2007
Decision Date August 22, 2007
Days to Decision 92 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 130d · This submission: 92d
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 64
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K071422.
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148 · Merit Medical Systems, Inc. · Apr 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101 · C.R. Bard, Inc. · Feb 2009
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
K080400 · AngioDynamics, Inc. · May 2008
MEDCOMP SPLIT CATH II
K051280 · Medcomp · Nov 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748 · C.R. Bard, Inc. · Aug 2005
MEDCOMP SPLIT-CATH II
K040318 · Medcomp · Feb 2005