510(k) K252459 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
multiFlux 130 (F00013123); multiFlux 160 (F00013124)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Feb 10, 2026 |
| Received | Aug 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252459
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.