# K972066: Belzer-MPS

- Pathway: 510(k) (Traditional)
- Applicant: Trans-Med Corp.
- Decided: Nov 26, 1997 after 176 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K121736: Perf-Gen Pulsatile Perfusion Solution (2013), 2 descendants of its own
- K080432: Mapersol (2008), 1 descendant of its own
- K243840: Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (2025), 0 descendants of its own
- K221386: PERF-GEN Pulsatile Perfusion Solution (2022), 0 descendants of its own
- K211842: Servator M SALF Solution (2021), 0 descendants of its own

## Indications for use
Belzer-MPS™ is the UW-gluconate perfusion solution indicated for the flushing and continuous hypothermic machine perfusion of donor kidneys.

Source page: https://510kreport.com/device/K972066
Methodology: https://510kreport.com/methodology