# K013575: KPS-I, the Kidney Perfusion Solution

- Pathway: 510(k) (Traditional)
- Applicant: Organ Recovery Systems, Inc.
- Decided: Jan 25, 2002 after 88 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.
3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Belzer MPS™ (UW Kidney Preservation Solution): named in the summary without a submission number

## Most influential descendants
- K022391: Modification to KPS-1, Kidney Perfusion Solutiion (2002), 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

## Indications for use
KPS-I™ 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/K013575
Methodology: https://510kreport.com/methodology