# K191006: EasiSlush

- Pathway: 510(k) (Traditional)
- Applicant: Bridge TO Life, Ltd.
- Decided: Sep 24, 2019 after 161 days
- Product code: KDN (System, Perfusion, Kidney)
- 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: 2 generations back to K944866 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073693: Costorsol, Preservation Solutions, Inc. (2008) Summary page 4.

## Most influential descendants
- K243618: EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation  (BTLE-1250) (2025), 0 descendants of its own

## Recalls of this device
- Jun 12, 2025 · Class II · Z-2157-2025: The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing w

## Indications for use
EasiSlush™ slushed solution is intended for topical cooling of in-situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient. EasiSlush™ slushed solution is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport. Organ Recovery Prior to organ recovery, EasiSlush™ slushed solution is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery. During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional EasiSlush slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ). Organ Storage/Transport For organ storage/transport, EasiSlush™ slushed solution may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, EasiSlush may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.

Source page: https://510kreport.com/device/K191006
Methodology: https://510kreport.com/methodology