De Novo · Granted
GrantedVitaSmart Hypothermic Oxygenated Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bridge TO Life, Ltd. · SGY Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Granted on Jan 15, 2026 as a new device type through De Novo after a 290-day review.
- Decided
- Jan 15, 2026
- Review
- 290 days
- Class
- Class II
- Product code
- SGY
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SGY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SGY devicesSGY Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SGY
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SGY
Too few SGY 510(k)s in any year since 2007 to give a median.
Recalls per year · SGY
No recall names SGY since 2007.
Adverse event reports per year · SGY
No MAUDE report names SGY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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)…
Read the full statement (114 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250009 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250009: VitaSmart Hypothermic Oxygenated Perfusion System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026