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Bel-Gen Cold Storage Solution

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121618

by Waters Medical Systems, LLC

Identifiers

510(k) Number
K121618 FDA 510(k)
FDA Product Code
KDL 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 Bel-Gen Cold Storage Solution is a Set, Perfusion, Kidney, Disposable device designed for the cold storage of kidney grafts. It provides a controlled environment to preserve kidney transplants prior to implantation, maintaining graft viability during transport and storage.

This device is intended for single-use and is regulated under FDA 510(k) clearance (K121618) for use in gastroenterology and urology settings. Supplied sterile, it adheres to regulatory standards for kidney perfusion systems, ensuring compatibility with cold preservation protocols. Storage and handling follow sterile procedures to prevent contamination, with no MRI safety considerations specified.

Frequently asked questions

What is the Bel-Gen Cold Storage Solution designed to do and where is it typically used?

The Bel-Gen Cold Storage Solution is specifically designed to provide a controlled, sterile environment for the cold storage of kidney grafts before transplantation. It helps maintain graft viability during transport and storage, ensuring the kidney remains viable for implantation. This device is primarily used in gastroenterology and urology settings, where kidney perfusion and preservation protocols are critical.

Is the Bel-Gen Cold Storage Solution meant for single-use or repeated use, and how is it supplied?

The Bel-Gen Cold Storage Solution is intended for single-use only, as explicitly stated in its design. It is supplied sterile, meaning it is pre-sterilized and ready for immediate use without additional sterilization steps, which helps prevent contamination during storage and handling.

What regulatory pathway does the Bel-Gen Cold Storage Solution follow, and what does that mean for its use?

The Bel-Gen Cold Storage Solution follows the FDA 510(k) clearance pathway, with a clearance number of K121618. This means it has been deemed substantially equivalent to a legally marketed device and is approved for use in the U.S. under FDA regulations. The clearance is tied to gastroenterology and urology settings, confirming its intended use in kidney graft preservation.

Are there any special handling or storage requirements for the Bel-Gen Cold Storage Solution?

Since the device is sterile and single-use, it must be handled using aseptic techniques to avoid contamination. While specific storage instructions aren’t detailed in the data, standard sterile storage practices—such as keeping it in a clean, dry environment and protecting it from physical damage—should be followed. There are no MRI safety considerations mentioned, so it can be safely used in non-MRI environments.

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: K121618 FDA 510 (k) - BEL-GEN COLD STORAGE SOLUTION, Waters Medical Systems, BEL-GEN COLD STORAGE SOLUTION (K121618) — FDA 510(k) | Innolitics, BEL-GEN COLD STORAGE… — K121618 · DeviceClearance, FDA Browser - Cleared 510 (K) - BEL-GEN COLD STORAGE SOLUTION (K121618)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Waters Medical Systems, LLC

Sources (1)

  • FDA 510(k) K121618 24 fields · synced Sep 20, 2026