# K073693: Costorsol

- Pathway: 510(k) (Traditional)
- Applicant: Preservation Solutions, Inc.
- Decided: Jul 3, 2008 after 185 days
- Product code: KDN (System, Perfusion, Kidney)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944866 (1996). 1 ancestor in all.
13 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944866: Viaspan (Belzer UW - CSS), The Dupont Merck Pharmaceutical Co. (1996) Summary page 1.

## Most influential descendants
- K083453: Costorsol (2009), 10 descendants of its own
- K091245: Costorsol (2009), 8 descendants of its own
- K133694: Sherpa Pak Transporter (2014), 3 descendants of its own
- K191006: EasiSlush (2019), 1 descendant of its own
- K180194: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (2018), 1 descendant of its own

## Recalls of this device
- Feb 26, 2018 · Class II · Z-1387-2018: Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..
- Sep 24, 2010 · Not classified · Z-0427-2011: Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.

## 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/K073693
Methodology: https://510kreport.com/methodology