# K121618: Bel-Gen Cold Storage Solution

- Pathway: 510(k) (Traditional)
- Applicant: Waters Medical Systems, LLC
- Decided: Jun 14, 2013 after 378 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) SPS-1™ Static Preservation Solution: named in the summary without a submission number

## Most influential descendants
- K221387: BEL-GEN Cold Storage Solution (2022), 0 descendants of its own

## 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/K121618
Methodology: https://510kreport.com/methodology