multiFlux 130 (F00013123); multiFlux 160 (F00013124)— 510(k) K252459
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K252459 for multiFlux 130 (F00013123); multiFlux 160 (F00013124), Substantially Equivalent on 2026-02-10. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.
Summary
Fresenius Medical Care Renal Therapies Group lists multiFlux 130 (F00013123) and multiFlux 160 (F00013124) under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). The record doesn't say how the two differ.
Class II, 21 CFR 876.5860. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Fresenius Medical Care filed from Waltham, Massachusetts. The substantially equivalent decision came 189 calendar days after receipt (August 5, 2025 to February 10, 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.