# P180014: XPS™ with Steen Solution™ Perfusate

- Pathway: PMA
- Applicant: Xvivo Perfusion, Inc.
- Decided: Apr 26, 2019 after 351 days
- Product code: PHO (Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 8, 2022 · Class II · Z-1212-2022: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

Source page: https://510kreport.com/device/P180014
Methodology: https://510kreport.com/methodology