# K243384: Belzer UW® Cold Storage Solution (BTLBUW-001)

- Pathway: 510(k) (Traditional)
- Applicant: Bridge TO Life
- Decided: Mar 31, 2025 after 151 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: 4 generations back to K944866 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091245: Costorsol, Preservation Solutions, Inc. (2009) Summary page 5.

## Indications for use
Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated 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. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.

Source page: https://510kreport.com/device/K243384
Methodology: https://510kreport.com/methodology