# K091989: Perfadex and Perfadex with Tham

- Pathway: 510(k) (Special)
- Applicant: Xvivo Perfusion AB
- Decided: Oct 1, 2010 after 456 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: 3 generations back to K000881 (2001). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000881: Perfadex Solution for Organ Preservation, Vitrolife Sweden AB (2001) Summary page 1.
- K081997: Perfadex with Tham, Vitrolife Sweden AB (2008) Summary page 1.

## Most influential descendants
- K170826: Perfadex Plus (2018), 2 descendants of its own
- K240650: LungProtect (2024), 1 descendant of its own
- K261644: Perfadex Plus (2026), 0 descendants of its own
- K243870: X°Port Lung Preservation System; X°Port Lung Preservation Solution (2025), 0 descendants of its own
- K230193: Servator P Plus SALF Solution (2023), 0 descendants of its own

## Indications for use
Perfadex® Solution for Lung Perfusion is indicated for the 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/K091989
Methodology: https://510kreport.com/methodology