Cleared Traditional

HEMO-CATH II KIDNEY DIALYSIS CATHETER (K801966) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801966 · Medical Components, Inc. · Gastroenterology & Urology device
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Sep 1980
Decision
38d
Days
Class 2
Risk

K801966 is an FDA 510(k) clearance for the HEMO-CATH II KIDNEY DIALYSIS CATHETER. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 38 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

Submission Details

510(k) Number K801966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date September 26, 1980
Days to Decision 38 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
92d faster than avg
Panel avg: 130d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIE Needle, Fistula
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 - FIE Needle, Fistula

All 8
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K801966.
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
K801618 · Sherwood Medical Co. · Aug 1980
A.V. FISTULA NEEDLE SET
K782021 · Cordis Corp. · Mar 1979