# K083453: Costorsol

- Pathway: 510(k) (Traditional)
- Applicant: Preservation Solutions, Inc.
- Decided: Jan 21, 2009 after 61 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 K944866 (1996). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073693: Costorsol, Preservation Solutions, Inc. (2008) Summary page 1.

## Most influential descendants
- K091245: Costorsol (2009), 8 descendants of its own
- K133694: Sherpa Pak Transporter (2014), 3 descendants of its own
- K180194: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (2018), 1 descendant of its own
- K091656: SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L (2010), 1 descendant of its own
- K261913: X°Port Heart Preservation System (2026), 0 descendants of its own

## Indications for use
CoStorSol® 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/K083453
Methodology: https://510kreport.com/methodology