# K080432: Mapersol

- Pathway: 510(k) (Traditional)
- Applicant: Preservation Solutions, Inc.
- Decided: Aug 8, 2008 after 171 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: 2 generations back to K013575 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972066: Belzer-MPS, Trans-Med Corp. (1997) Summary page 1.
- K022391: Modification to KPS-1, Kidney Perfusion Solutiion, Organ Recovery Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K243840: Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (2025), 0 descendants of its own

## Indications for use
MaPerSol® organ preservation solution is intended for in-vitro flushing and continuous hypothermic machine perfusion of explanted kidneys.

Source page: https://510kreport.com/device/K080432
Methodology: https://510kreport.com/methodology