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Custodiol HTK Solution

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192408

by Dr. Franz Köhler Chemie GmbH

Identifiers

510(k) Number
K192408 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)

Custodiol HTK Solution is a disposable perfusion set for the kidney, heart, liver, and pancreas. It functions as a cardioplegic and organ preservation solution designed for flushing and storing donor organs prior to transplantation.

This solution is supplied by Dr. Franz Köhler Chemie GmbH and has received FDA 510K clearance. It is intended for use in the hypothermic storage and transport of organs to the recipient.

Frequently asked questions

What is the primary purpose of Custodiol HTK Solution?

This device is a disposable perfusion set designed for the flushing and hypothermic storage of donor organs, including the heart, kidney, liver, and pancreas, to maintain them during transport prior to transplantation.

Is this device intended for single use?

Yes, the product is classified as a disposable perfusion set. It is intended for a single use during the organ preservation process to ensure sterility and prevent cross-contamination between donor procedures.

What is the regulatory status of this perfusion set?

Custodiol HTK Solution has received FDA 510K clearance under the K-number K192408. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

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: CUSTODIOL HTK Solution | Dr. Köhler Medikal, Custodiol HTK | The Clear Choice, CUSTODIOL® HTK Solution — Koehler Pharmaceutical Asia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dr. Franz Köhler Chemie GmbH
FDA Applicant
Dr. Franz Kohler Chemie GmbH

Sources (1)

  • FDA 510(k) K192408 24 fields · synced Oct 6, 2026