Cleared Traditional

HEMO-CATH I, KIDNEY DIALYSIS CATHETER (K761078) - FDA 510(k) Clearance

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

K761078 · Medical Disposables Intl., Inc. · Gastroenterology & Urology device
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Dec 1976
Decision
17d
Days
Class 2
Risk

K761078 is an FDA 510(k) clearance for the HEMO-CATH I, KIDNEY DIALYSIS CATHETER. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Medical Disposables Intl., Inc. (Walker, US). The FDA issued a Cleared decision on December 6, 1976 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Disposables Intl., Inc. devices

Submission Details

510(k) Number K761078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1976
Decision Date December 06, 1976
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 25
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K761078.
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
K801356 · Cordis Corp. · Jul 1980
HEMODIALYSIS BLOOD CIRCUIT
K790591 · Travenol Laboratories, S.A. · May 1979
PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2
K770475 · Travenol Laboratories, S.A. · Mar 1977
BLOOD TUBING SETS
K760042 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976