# K022391: Modification to KPS-1, Kidney Perfusion Solutiion

- Pathway: 510(k) (Special)
- Applicant: Organ Recovery Systems, Inc.
- Decided: Oct 21, 2002 after 90 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: 1 generation back to K013575 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013575: KPS-I, the Kidney Perfusion Solution, Organ Recovery Systems, Inc. (2002) Summary page 3.

## Most influential descendants
- K080432: Mapersol (2008), 1 descendant of its own
- K243840: Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (2025), 0 descendants of its own

## Indications for use
KPS-1™, The Kidney Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K022391
Methodology: https://510kreport.com/methodology