# K170826: Perfadex Plus

- Pathway: 510(k) (Traditional)
- Applicant: Xvivo Perfusion AB
- Decided: Jun 22, 2018 after 459 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.
2 later devices descend from it; 2 cite it directly.
0 of 7 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.

## Most influential descendants
- K261644: Perfadex Plus (2026), 0 descendants of its own
- K230193: Servator P Plus SALF Solution (2023), 0 descendants of its own

## Indications for use
Perfadex Plus is indicated for the flushing, static cold 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/K170826
Methodology: https://510kreport.com/methodology