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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 131d · 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 112
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K071422.
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
K073093 · Spire Biomedical, Inc. · Jan 2008
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
K071202 · Dermaport, Inc. · Nov 2007
NOVOFLO CATHETER LT
K072499 · Novosci, Inc. · Oct 2007
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS
K070572 · Ash Access Technology, Inc. · Jun 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
K063441 · Spire Biomedical, Inc. · Feb 2007
HEMOCATH II
K062901 · Med-Conduit, Inc. · Feb 2007