Cleared Traditional

CATHETER, KIDNEY DIALYSIS, HEMO-CATH II (K770552) - FDA 510(k) Clearance

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

K770552 · Medical Disposables Intl., Inc. · Gastroenterology & Urology device
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Mar 1977
Decision
9d
Days
Class 2
Risk

K770552 is an FDA 510(k) clearance for the CATHETER, KIDNEY DIALYSIS, HEMO-CATH II. 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 March 30, 1977 after a review of 9 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 K770552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1977
Decision Date March 30, 1977
Days to Decision 9 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
121d faster than avg
Panel avg: 130d · This submission: 9d
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 K770552.
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K801355 · Cordis Corp. · Jul 1980
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