NxStage System One with NxView— 510(k) K252377
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K252377 for NxStage System One with NxView, Substantially Equivalent on 2026-05-15. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.
Summary
Fresenius Medical Care Renal Therapies Group filed the NxStage System One with NxView under KDI, high permeability dialyzers with or without sealed dialysate system.
Class II, 21 CFR 876.5860. Gastroenterology and Urology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Fresenius filed from Waltham, Massachusetts. The decision came 289 calendar days after receipt (July 30, 2025 to May 15, 2026).
Clearance details
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Product code
- Product code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code KDI
view allMore clearances from Fresenius Medical Care Renal Therapies Group, LLC
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.