# K991594: Celsior Cold Flush, Storage and Transport Solution for Hearts

- Pathway: 510(k) (Traditional)
- Applicant: Sangstat Medical Corp.
- Decided: Aug 5, 1999 after 90 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- 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
Longest line of descent: 1 generation back to K883782 (1989). 2 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900492: Labeling Change - Viaspan (TM) (Belzer UW), The DU Pont Co. (1990) Summary page 2.
- K883782: Belzer UW-CSS, Du Pont Critical Care (1989) Summary page 2.

## Most influential descendants
- K123326: Sherpa Pak Cardiac Transport System (2013), 6 descendants of its own
- K133694: Sherpa Pak Transporter (2014), 3 descendants of its own
- K133432: Sherpa Pak Cardiac Transport System (2014), 3 descendants of its own
- K180194: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (2018), 1 descendant of its own
- K032794: Custodiol (2004), 1 descendant of its own

## Recalls of this device
- Mar 13, 2025 · Class II · Z-2220-2025: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

## Indications for use
Celsior is intended for flushing and cold storage of a heart at the time of its removal from a donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K991594
Methodology: https://510kreport.com/methodology