Cleared Traditional

K902426 - HEMODIALYSIS SYSTEM AND ACCESSORY (FDA 510(k) Clearance)

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

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 75
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K902426.
VITAL Tubing Sets for Hemodialysis
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Moda-flx Hemodialysis System™ Cartridge (102121-001 )
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CombiSet Hemodialysis Blood Tubing Set
K213992 · Fresenius Medical Care Renal Therapies Group, LLC · May 2023
Tablo Cartridge
K210782 · Outset Medical, Inc. · Nov 2021
SANSIN Tubing Sets for Hemodialysis
K202796 · Jiangxi Sanxin Medtec Co., Ltd. · Sep 2021