# K022730: Perfadex Solution for Lung Preservation

- Pathway: 510(k) (Traditional)
- Applicant: Vitrolife AB
- Decided: Oct 27, 2003 after 437 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
Longest line of descent: 1 generation back to K000881 (2001). 1 ancestor in all.
9 later devices descend from it; 1 cites 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)

## Most influential descendants
- 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
- K261644: Perfadex Plus (2026), 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/K022730
Methodology: https://510kreport.com/methodology