Cleared Traditional

K151728 - CoStorSol plus G

K151728 is an FDA 510(k) clearance for CoStorSol plus G, 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 84-day FDA review.

K151728 · Preservation Solutions, Inc. · Gastroenterology & Urology device
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Sep 2015
Decision
84d
Days
Class 2
Risk

K151728 is an FDA 510(k) clearance for the CoStorSol plus G. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Preservation Solutions, Inc. (Elkhorn, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 84 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 Preservation Solutions, Inc. devices

FDA 510(k) Submission Details - K151728

510(k) Number K151728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2015
Decision Date September 18, 2015
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 131d · This submission: 84d
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.

Regulatory Consultant

Neil Burris & Associates
NEIL BURRIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KDN System, Perfusion, Kidney

All 37
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