510(k) K254305 ยท KDN System, Perfusion, Kidney
BAROguard Donor Lung Preservation System
| Applicant | Paragonix Technologies, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jan 30, 2026 |
| Received | Dec 31, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254305
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.