Cleared Traditional

K842416 - DUO FLOW CATHETER-MC 54

K842416 is an FDA 510(k) clearance for DUO FLOW CATHETER-MC 54, manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNZ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K842416 · Medical Components, Inc. · Gastroenterology & Urology device
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Jul 1984
Decision
36d
Days
Class 2
Risk

K842416 is an FDA 510(k) clearance for the DUO FLOW CATHETER-MC 54. Classified as Accessories, A-v Shunt (product code KNZ), Class II - Special Controls.

Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1984 after a review of 36 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Components, Inc. devices

FDA 510(k) Submission Details - K842416

510(k) Number K842416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1984
Decision Date July 26, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 130d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNZ Device Classification - Class 2, Special Controls

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 K842416.
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER
K842039 · Argon Medical Corp. · Jan 1985
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