# K000881: Perfadex Solution for Organ Preservation

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife Sweden AB
- Decided: Mar 8, 2001 after 353 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- 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
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022730: Perfadex Solution for Lung Preservation (2003), 9 descendants of its own
- K081997: Perfadex with Tham (2008), 8 descendants of its own
- K091989: Perfadex and Perfadex with Tham (2010), 7 descendants of its own
- K170826: Perfadex Plus (2018), 2 descendants of its own
- K240650: LungProtect (2024), 1 descendant of its own

Source page: https://510kreport.com/device/K000881
Methodology: https://510kreport.com/methodology