# K153384: Low Potassium Dextran Solution with Tris Diluent

- Pathway: 510(k) (Traditional)
- Applicant: United Therapeutics Corporation
- Decided: Feb 19, 2016 after 88 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: 4 generations back to K000881 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091989: Perfadex and Perfadex with Tham, Xvivo Perfusion AB (2010) Summary page 4.

## Indications for use
Low Potassium Dextran Solution with Tris Diluent is indicated for 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/K153384
Methodology: https://510kreport.com/methodology