Cleared Special

K022391 - MODIFICATION TO KPS-1

K022391 is an FDA 510(k) clearance for MODIFICATION TO KPS-1, manufactured by Organ Recovery Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Special 510(k) pathway after a 90-day FDA review.

K022391 · Organ Recovery Systems, Inc. · Gastroenterology & Urology device
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Oct 2002
Decision
90d
Days
Class 2
Risk

K022391 is an FDA 510(k) clearance for the MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Organ Recovery Systems, Inc. (Charleston, US). The FDA issued a Cleared decision on October 21, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Organ Recovery Systems, Inc. devices

FDA 510(k) Submission Details - K022391

510(k) Number K022391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2002
Decision Date October 21, 2002
Days to Decision 90 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

KDN Device Classification - Class 2, Special Controls

Product Code KDN System, Perfusion, Kidney
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.