# K221387: BEL-GEN Cold Storage Solution

- Pathway: 510(k) (Traditional)
- Applicant: Institut Georges Lopez
- Decided: Jun 14, 2022 after 32 days
- Product code: KDL (Set, Perfusion, Kidney, Disposable)
- 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: 4 generations back to K944866 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121618: Bel-Gen Cold Storage Solution, Waters Medical Systems, LLC (2013) Summary page 4.
- K091245: Costorsol, Preservation Solutions, Inc. (2009) Summary page 4.

## Indications for use
The BEL-GEN Cold Storage Solution is intended for the flushing and the hypothermic 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/K221387
Methodology: https://510kreport.com/methodology