# DEN250009: VitaSmart Hypothermic Oxygenated Perfusion System

- Pathway: De Novo (Direct)
- Applicant: Bridge TO Life, Ltd.
- Decided: Jan 15, 2026 after 290 days
- Product code: SGY (Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant)
- Device class: 2
- Regulation: 21 CFR 876.5881
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System is intended to be used for hypothermic oxygenated perfusion of donor livers, after a period of static cold storage (SCS), for eventual transplantation into a recipient. The VitaSmart HOPE System is not intended to be used while the organ is in transport. The device is indicated for use with Donation after Brain Death (DBD) donor livers ≤ 65 years old; or Donation after Circulatory Death (DCD) donor livers ≤ 55 years old and with ≤ 18 minutes of functional warm ischemic time with macrosteatosis ≤ 10%. The VitaSmart HOPE System is intended for use by qualified healthcare professionals trained in the use of the VitaSmart HOPE System.

Source page: https://510kreport.com/device/DEN250009
Methodology: https://510kreport.com/methodology