# K944866: Viaspan (Belzer UW - CSS)

- Pathway: 510(k) (Traditional)
- Applicant: The Dupont Merck Pharmaceutical Co.
- Decided: Apr 22, 1996 after 567 days
- Product code: KDL (Set, Perfusion, Kidney, Disposable)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 6 cite it directly.
0 of 21 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) Collins' solution: named in the summary without a submission number
- (no number) EuroCollins' solution: named in the summary without a submission number

## Most influential descendants
- K073693: Costorsol (2008), 13 descendants of its own
- K083453: Costorsol (2009), 10 descendants of its own
- K091245: Costorsol (2009), 8 descendants of its own
- K992209: Custodiol (1999), 6 descendants of its own
- K020924: Custodiol HTK Solution (2003), 5 descendants of its own

## Recalls of this device
- Mar 30, 2012 · Not classified · Z-1437-2012: Lack of assurance of sterility

## Indications for use
BELZER UW-CSS can be used for cold storage of the liver, pancreas, and kidney.

Source page: https://510kreport.com/device/K944866
Methodology: https://510kreport.com/methodology