DEN250009 is an FDA 510(k) submission for the VitaSmart Hypothermic Oxygenated Perfusion System. This device is classified as a Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant (Class II - Special Controls, product code SGY).
Submitted by Bridge TO Life, Ltd. (Northbrook, US). The FDA issued a Not Cleared (DENG) decision on January 15, 2026.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5881. A Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Is A Device That Performs Oxygenated Perfusion Of Liver Grafts At Sub-physiological Temperatures Until It Is Transplanted Into A Recipient Patient. This Generic Type Of Device May Also Include Perfusion Sets, Oxygenators, And Other Components Of The Perfusion Circuit..
| 510(k) Number | DEN250009 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 31, 2025 |
| Decision Date | January 15, 2026 |
| Days to Decision | 290 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | SGY - Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5881 |
| Definition | A Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Is A Device That Performs Oxygenated Perfusion Of Liver Grafts At Sub-physiological Temperatures Until It Is Transplanted Into A Recipient Patient. This Generic Type Of Device May Also Include Perfusion Sets, Oxygenators, And Other Components Of The Perfusion Circuit. |