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CoStorSol

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091245

by Preservation Solutions, Inc.

Identifiers

510(k) Number
K091245 FDA 510(k)
FDA Product Code
KDN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5880 FDA 510(k)
Regulation Number
876.5880 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CoStorSol is a sterile, non-pyrogenic perfusion solution designed for hypothermic flushing and storage of organs. Classified as a System, Perfusion, Kidney, it maintains organ viability through controlled osmolarity (320 mosmol/kg) and balanced electrolyte composition, including sodium (29 mEq/L) and potassium (125 mEq/L) concentrations, at a physiological pH (~7.4). The solution is formulated to support extended preservation of transplanted organs while minimizing cellular damage during transport.

This solution is supplied as a clear to light yellow liquid, packaged in sterile containers for single-use. It is intended for use in clinical settings where organ transplantation is performed, adhering to regulatory standards for sterile medical devices. CoStorSol is authorized under FDA 510K clearance (K091245) and falls under Device Class II (regulation number 876.5880). Storage and handling must comply with sterile medical practice guidelines to ensure efficacy and safety during organ preservation procedures.

Frequently asked questions

What is CoStorSol primarily used for in clinical settings?

CoStorSol is a sterile perfusion solution specifically designed for hypothermic flushing and storage of kidneys during organ transplantation procedures. Its balanced electrolyte composition and controlled osmolarity (320 mosmol/kg) help maintain organ viability and reduce cellular damage during transport, ensuring the organ remains viable for transplantation.

Is CoStorSol intended for reuse, or is it meant for single-use only?

CoStorSol is supplied in sterile containers and is explicitly intended for single-use only. This ensures sterility and safety during organ preservation, adhering to clinical best practices for sterile medical devices.

How should CoStorSol be stored, and what are the key considerations for handling?

CoStorSol must be stored and handled according to sterile medical practice guidelines to preserve its efficacy and safety. Since it is a sterile, non-pyrogenic solution, it should be kept in its original packaging until use, protected from contamination, and stored in a way that maintains its integrity until clinical application.

What are the key electrolyte and pH characteristics of CoStorSol that make it suitable for organ preservation?

CoStorSol is formulated with a physiological pH of approximately 7.4, along with carefully balanced electrolyte levels—including sodium (29 mEq/L) and potassium (125 mEq/L)—to replicate the natural extracellular environment. This composition helps minimize cellular damage and supports extended preservation of kidneys during transport.

What regulatory pathway was followed for CoStorSol’s approval, and what class does it fall under?

CoStorSol was authorized through the FDA’s 510(k) clearance process (K091245) under a traditional review pathway, determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulation number 876.5880, which governs perfusion systems for kidneys.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CoStorSol® - Preservation Solutions, Preservation Solutions, Products - Preservation Solutions, PDF CoStorSol RM/N 4010 Cold Storage Solution - Preservation Solutions

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Preservation Solutions, Inc.

Sources (1)

  • FDA 510(k) K091245 24 fields · synced Sep 20, 2026