# K192408: Custodiol HTK Solution

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Franz Kohler Chemie GmbH
- Decided: Apr 24, 2020 after 233 days
- Product code: KDL (Set, Perfusion, Kidney, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944866 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043461: Custodiol, Dr. Franz Kohler Chemie GmbH (2005) Summary page 5.

## Most influential descendants
- K241239: OrganProtex HTK Solution (2025), 0 descendants of its own

## Recalls of this device
- Jan 9, 2024 · Class II · Z-3300-2024: Potential for particles to be present in solution.

## Indications for use
CUSTODIOL® HTK solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. CUSTODIOL® HTK solution is not indicated for continuous machine perfusion of donor organs.

Source page: https://510kreport.com/device/K192408
Methodology: https://510kreport.com/methodology