Identifiers
- 510(k) Number
- K073693 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)
The CoStorSol Preservation Solution is a sterile, non-pyrogenic perfusion system designed for hypothermic flushing and storage of kidneys. It is formulated as a clear to light yellow liquid with an osmolarity of approximately 320 mosmol/kg, balancing sodium (29 mEq/L) and potassium (125 mEq/L) concentrations to maintain cellular integrity during organ preservation.
Supplied as a single-use solution, CoStorSol is intended for use in clinical settings where kidney transplantation is performed. It is regulated under FDA 510(k) clearance (K073693) and classified as a Class II medical device (regulation number 876.5880). The solution is packaged for sterile use and must be stored according to manufacturer guidelines to ensure viability prior to application.
Frequently asked questions
What is the primary purpose of the CoStorSol Preservation Solution and how does it differ from standard saline flushes for kidney transplantation?
The CoStorSol Preservation Solution is specifically designed for hypothermic flushing and storage of kidneys to maintain cellular integrity during preservation. Unlike standard saline flushes, it contains a balanced osmolarity of approximately 320 mosmol/kg with carefully formulated sodium (29 mEq/L) and potassium (125 mEq/L) concentrations, which helps protect kidney cells during prolonged storage. This formulation is tailored for clinical settings where kidney transplantation is performed, ensuring better organ viability compared to generic saline solutions.
Is the CoStorSol Preservation Solution reusable or intended for single-use only, and how should it be stored?
The CoStorSol Preservation Solution is supplied as a single-use sterile liquid, meaning each package is intended for one-time clinical application only. To maintain its viability, it must be stored according to the manufacturer’s guidelines—typically in a cool, dry place away from direct sunlight until use. Proper storage ensures the solution remains non-pyrogenic and effective for hypothermic preservation.
What regulatory pathway was followed for the CoStorSol Preservation Solution, and what classification does it hold?
The CoStorSol Preservation Solution was cleared through the FDA 510(k) pathway under the classification of a Class II medical device (regulation number 876.5880). This clearance was granted on July 3, 2008, after demonstrating substantial equivalence to a predicate device. The solution is also listed under product code KDN, which aligns with perfusion systems for kidney preservation.
What color variations can be expected in the CoStorSol Preservation Solution, and does this affect its performance?
The CoStorSol Preservation Solution is described as a clear to light yellow liquid, with the slight yellow tint being normal and not indicative of degradation. This color variation is part of its formulation and does not impact its osmolarity, electrolyte balance, or ability to maintain cellular integrity during kidney preservation. Always verify the solution’s appearance before use to ensure it remains within the expected range.
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, COSTORSOL - Preservation Solutions, Inc. Trademark Registration, COSTORSOL (K073693) — FDA 510 (k) | Innolitics, Preservation Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073693 | Class II | Active |
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Manufacturer
- Manufacturer
- Preservation Solutions, Inc.
Sources (1)
- FDA 510(k) K073693 24 fields · synced Sep 19, 2026