# K091656: SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L

- Pathway: 510(k) (Traditional)
- Applicant: Organ Recovery Systems, Inc.
- Decided: Mar 11, 2010 after 275 days
- Product code: KDL (Set, Perfusion, Kidney, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944866 (1996). 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)
- K083453: Costorsol, Preservation Solutions, Inc. (2009) Summary page 1.
- K073693: Costorsol, Preservation Solutions, Inc. (2008) Summary page 1.
- K944866: Viaspan (Belzer UW - CSS), The Dupont Merck Pharmaceutical Co. (1996) Summary page 1.

## Most influential descendants
- K143054: Sherpa Pak Kidney Transport System (2014), 0 descendants of its own

## Recalls of this device
- Dec 14, 2016 · Class II · Z-1111-2017: Organ preservation fluid recalled due to potential for bacterial contamination.

## Indications for use
SPS_1TM is intended for the flushing and cold storage of kidney, liver, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K091656
Methodology: https://510kreport.com/methodology