K243840 is an FDA 510(k) clearance for the Belzer MPS? (UW Machine Perfusion Solution) (BMPS-001), a System, Perfusion, Kidney (Class II — Special Controls, product code KDN), submitted by Bridge TO Life (Northbrook, US). The FDA issued a Cleared decision on March 26, 2025, 103 days after receiving the submission on December 13, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K243840 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 13, 2024 |
| Decision Date | March 26, 2025 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDN — System, Perfusion, Kidney |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5880 |