K254305 is an FDA 510(k) clearance for the BAROguard Donor Lung Preservation System. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Paragonix Technologies, Inc. (Waltham, US). The FDA issued a Cleared decision on January 30, 2026, 30 days after receiving the submission on December 31, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K254305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2025 |
| Decision Date | January 30, 2026 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDN - System, Perfusion, Kidney |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |