Cleared Traditional

K080432 - MAPERSOL

K080432 is an FDA 510(k) clearance for MAPERSOL, manufactured by Preservation Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K080432 · Preservation Solutions, Inc. · Gastroenterology & Urology device
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Aug 2008
Decision
171d
Days
Class 2
Risk

K080432 is an FDA 510(k) clearance for the MAPERSOL. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Preservation Solutions, Inc. (Denver, US). The FDA issued a Cleared decision on August 8, 2008 after a review of 171 days - an extended review 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: 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 Preservation Solutions, Inc. devices

FDA 510(k) Submission Details - K080432

510(k) Number K080432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date August 08, 2008
Days to Decision 171 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 130d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.