# K241239: OrganProtex HTK Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bridge TO Life, Ltd.
- Decided: Jan 24, 2025 after 266 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: 5 generations back to K944866 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192408: Custodiol HTK Solution, Dr. Franz Kohler Chemie GmbH (2020) Summary page 5.

## Indications for use
The OrganProtex™ 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. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.

Source page: https://510kreport.com/device/K241239
Methodology: https://510kreport.com/methodology