# K261644: Perfadex Plus

- Pathway: 510(k) (Traditional)
- Applicant: Xvivo Perfusion AB
- Decided: Jul 23, 2026 after 66 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: 5 generations back to K000881 (2001). 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)
- K170826: Perfadex Plus, Xvivo Perfusion AB (2018) Summary page 5.

## 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/K261644
Methodology: https://510kreport.com/methodology