# K202652: Servator P SALF Solution with THAM

- Pathway: 510(k) (Traditional)
- Applicant: S.A.L.F. Spa
- Decided: Aug 19, 2021 after 339 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 K000881 (2001). 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)
- K091989: Perfadex and Perfadex with Tham, Xvivo Perfusion AB (2010) Summary page 4.

## Indications for use
Servator P SALF Solution with THAM is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K202652
Methodology: https://510kreport.com/methodology