510(k) K252377 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage System One with NxView
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 15, 2026 |
| Received | Jul 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252377
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.