Cleared Traditional

K900492 - LABELING CHANGE - VIASPAN(TM) (BELZER UW)

K900492 is an FDA 510(k) clearance for LABELING CHANGE - VIASPAN(TM) (BELZER UW), manufactured by The DU Pont Co.. The device is a Class 2 Gastroenterology & Urology device with product code KDL cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K900492 · The DU Pont Co. · Gastroenterology & Urology device
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Mar 1990
Decision
46d
Days
Class 2
Risk

K900492 is an FDA 510(k) clearance for the LABELING CHANGE - VIASPAN(TM) (BELZER UW). Classified as Set, Perfusion, Kidney, Disposable (product code KDL), Class II - Special Controls.

Submitted by The DU Pont Co. (Wilmington, US). The FDA issued a Cleared decision on March 20, 1990 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - 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 The DU Pont Co. devices

FDA 510(k) Submission Details - K900492

510(k) Number K900492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1990
Decision Date March 20, 1990
Days to Decision 46 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
85d faster than avg
Panel avg: 131d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDL Device Classification - Class 2, Special Controls

Product Code KDL Set, Perfusion, Kidney, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
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 - KDL Set, Perfusion, Kidney, Disposable

All 16
Devices cleared under the same product code (KDL) and FDA review panel - the closest regulatory comparables to K900492.
CUSTODIOL
K043461 · Dr. Franz Kohler Chemie GmbH · Feb 2005
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
K955497 · Cobe Renal Care, Inc. · Sep 1997
VIASPAN (BELZER UW - CSS)
K944866 · The Dupont Merck Pharmaceutical Co. · Apr 1996
MOP CATHETER
K891239 · Bivona Medical Technologies · Nov 1989
EURO-COLLINS SOLUTION SETS
K884609 · Fresenius USA, Inc. · Jan 1989
H.P. MEDICAL GRADE SILICONE TUBING
K780470 · Dow Corning Corp. Healthcare Industries Materials · Apr 1978