# K081997: Perfadex with Tham

- Pathway: 510(k) (Special)
- Applicant: Vitrolife Sweden AB
- Decided: Oct 9, 2008 after 87 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000881 (2001). 2 ancestors in all.
8 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)
- K022730: Perfadex Solution for Lung Preservation, Vitrolife AB (2003) Summary page 1.

## Most influential descendants
- 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
- K243870: X°Port Lung Preservation System; X°Port Lung Preservation Solution (2025), 0 descendants of its own

## Recalls of this device
- May 12, 2011 · Not classified · Z-2795-2011: Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.

## 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/K081997
Methodology: https://510kreport.com/methodology