Cleared Traditional

K842039 - ARGON DUAL LUMEN HEMODIALYSIS

K842039 is the FDA 510(k) clearance for ARGON DUAL LUMEN HEMODIALYSIS by Argon Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNZ) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K842039 · Argon Medical Corp. · Gastroenterology & Urology device
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Jan 1985
Decision
253d
Days
Class 2
Risk

K842039 is an FDA 510(k) clearance for the ARGON DUAL LUMEN HEMODIALYSIS, CATHETER. Classified as Accessories, A-v Shunt (product code KNZ), Class II - Special Controls.

Submitted by Argon Medical Corp. (Athens, US). The FDA issued a Cleared decision on January 29, 1985 after a review of 253 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 Argon Medical Corp. devices

Submission Details

510(k) Number K842039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1984
Decision Date January 29, 1985
Days to Decision 253 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 130d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNZ Accessories, A-v Shunt
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 - KNZ Accessories, A-v Shunt

Devices cleared under the same product code (KNZ) and FDA review panel - the closest regulatory comparables to K842039.
DUO FLOW CATHETER-MC 54
K842416 · Medical Components, Inc. · Jul 1984
DOUBLE LUMEN SUBLCAVIAN-FEMORAL
K841530 · Medical Components, Inc. · Jun 1984
HEMOCATH REPAIR KIT
K840424 · Quinton, Inc. · Mar 1984
HEMASITE ACCESSORIES MODIFICATION
K840437 · Renal Systems, Inc. · Feb 1984
RENAFLO AVF SET FOR HEMODIALYSIS
K834510 · Renal Systems, Inc. · Feb 1984