# K243840: Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

- Pathway: 510(k) (Traditional)
- Applicant: Bridge TO Life
- Decided: Mar 26, 2025 after 103 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: 3 generations back to K013575 (2002). 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)
- K080432: Mapersol, Preservation Solutions, Inc. (2008) Summary page 5.

## Indications for use
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) is indicated for the in vitro flushing and continuous hypothermic machine perfusion of explanted abdominal organs.

Source page: https://510kreport.com/device/K243840
Methodology: https://510kreport.com/methodology