Cleared Traditional

K900306 - HEMODIALYSIS BLOOD LINES

K900306 is the FDA 510(k) clearance for HEMODIALYSIS BLOOD LINES by Gainor Medical Europe, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K900306 · Gainor Medical Europe, Ltd. · Gastroenterology & Urology device
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Apr 1990
Decision
89d
Days
Class 2
Risk

K900306 is an FDA 510(k) clearance for the HEMODIALYSIS BLOOD LINES. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Gainor Medical Europe, Ltd. (Mcdonough, US). The FDA issued a Cleared decision on April 20, 1990 after a review of 89 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 Gainor Medical Europe, Ltd. devices

Submission Details

510(k) Number K900306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1990
Decision Date April 20, 1990
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
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 81
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K900306.
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