Cleared Traditional

K801966 - HEMO-CATH II KIDNEY DIALYSIS CATHETER

K801966 is an FDA 510(k) clearance for HEMO-CATH II KIDNEY DIALYSIS CATHETER, manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 38-day FDA review.

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

FDA 510(k) Submission Details - K801966

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
Combination Product No
PCCP Authorized No
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.

FIE Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K801966.
HOSPAL FISTULA NEEDLE
K851453 · Hospal Medical Corp. · Apr 1985
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983
GAMBRO A-V FISTULA NEEDLE SET
K802956 · Gambro, Inc. · Dec 1980
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
K801618 · Sherwood Medical Co. · Aug 1980
VITAL CATHETER
K791489 · Hospal Medical Corp. · Oct 1979
UNIPUNCTURE CATHETER
K791490 · Hospal Medical Corp. · Oct 1979