De Novo
DEN250009: VitaSmart Hypothermic Oxygenated Perfusion System
FDA De Novo · bridge to life, ltd. · decided Jan 15, 2026
Key facts
| De Novo number | DEN250009 |
|---|---|
| Device name | VitaSmart Hypothermic Oxygenated Perfusion System |
| Applicant | bridge to life, ltd. |
| Product code | SGY |
| Date received | Mar 31, 2025 |
| Decision date | Jan 15, 2026 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 3031884833 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: