# K170150: Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags

- Pathway: 510(k) (Traditional)
- Applicant: S.A.L.F. Spa
- Decided: Oct 20, 2017 after 276 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: 4 generations back to K944866 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
The Servator H SALF 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/K170150
Methodology: https://510kreport.com/methodology