# K043461: Custodiol

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Franz Kohler Chemie GmbH
- Decided: Feb 28, 2005 after 75 days
- Product code: KDL (Set, Perfusion, Kidney, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944866 (1996). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944866: Viaspan (Belzer UW - CSS), The Dupont Merck Pharmaceutical Co. (1996) Summary page 1.
- K992209: Custodiol, Dr. Franz Kohler Chemie GmbH (1999) Summary page 1.
- K020924: Custodiol HTK Solution, Dr. Franz Kohler Chemie GmbH (2003) Summary page 1.

## Most influential descendants
- K192408: Custodiol HTK Solution (2020), 1 descendant of its own
- K241239: OrganProtex HTK Solution (2025), 0 descendants of its own
- K170150: Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags (2017), 0 descendants of its own
- K143054: Sherpa Pak Kidney Transport System (2014), 0 descendants of its own

## Indications for use
Custodiol HTK Solution is indicated for perfusion and flushing 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 (not for continuous perfusion) to the recipient.

Source page: https://510kreport.com/device/K043461
Methodology: https://510kreport.com/methodology