# K254305: BAROguard Donor Lung Preservation System

- Pathway: 510(k) (Special)
- Applicant: Paragonix Technologies, Inc.
- Decided: Jan 30, 2026 after 30 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Paragonix BAROguard is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for BAROguard is up to 8 hours. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient. Note: Partial lungs can be transported via BAROguard by packaging lungs per institutional protocol and UNOS guidelines.

Source page: https://510kreport.com/device/K254305
Methodology: https://510kreport.com/methodology