# K180481: Servator B SALF Solution

- Pathway: 510(k) (Traditional)
- Applicant: S.A.L.F. Spa
- Decided: Jun 29, 2018 after 126 days
- Product code: KDN (System, Perfusion, Kidney)
- 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)
- K091245: Costorsol, Preservation Solutions, Inc. (2009) Summary page 4.

## Indications for use
Servator B SALF Solution is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K180481
Methodology: https://510kreport.com/methodology