# K032794: Custodiol

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Franz Kohler Chemie GmbH
- Decided: Apr 5, 2004 after 210 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- 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: 2 generations back to K883782 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991594: Celsior Cold Flush, Storage and Transport Solution for Hearts, Sangstat Medical Corp. (1999) Summary page 1.
- (no number) Custodiol product: named in the summary without a submission number

## Most influential descendants
- K143074: Sherpa Pak Cardiac Transport System (2014), 0 descendants of its own

## Indications for use
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, livers, and hearts 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/K032794
Methodology: https://510kreport.com/methodology