Cleared Traditional

K902426 - HEMODIALYSIS SYSTEM AND ACCESSORY

K902426 is the FDA 510(k) clearance for HEMODIALYSIS SYSTEM AND ACCESSORY by Gainor Medical Europe, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FJK) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K902426 · Gainor Medical Europe, Ltd. · Gastroenterology & Urology device
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Nov 1990
Decision
173d
Days
Class 2
Risk

K902426 is an FDA 510(k) clearance for the HEMODIALYSIS SYSTEM AND ACCESSORY. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Gainor Medical Europe, Ltd. (Mcdonough, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 173 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gainor Medical Europe, Ltd. devices

Submission Details

510(k) Number K902426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1990
Decision Date November 20, 1990
Days to Decision 173 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
43d slower than avg
Panel avg: 130d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 22
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K902426.
BRAUN HEMODIALYSIS BLOOD CIRCUITS
K952631 · B.Braun Medical, Inc. · Apr 1996
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803 · Baxter Healthcare Corp · Dec 1993
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
K910558 · Terumo Medical Corp. · Aug 1991
ASA BLOOD TUBING LINES
K854271 · Organon Teknika Corp. · Nov 1985
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
K831424 · Extracorporeal Medical Specialities, Inc. · Oct 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677 · Gambro, Inc. · Apr 1983