Careflux H60; Careflux H70; Careflux V500— 510(k) K261267
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K261267 for Careflux H60; Careflux H70; Careflux V500, Substantially Equivalent on 2026-07-24. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.
Summary
Fresenius Medical Care Renal Therapies Group's clearance covers Careflux H60, H70, and V500, filed under KDI, high permeability dialyzers with or without sealed dialysate system. The record doesn't say how the three differ.
Class II, 21 CFR 876.5860. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Fresenius filed from Waltham, Massachusetts. The decision came 99 calendar days after receipt (April 16 to July 24, 2026).
Clearance details
- Device name as filed
- Careflux H60;Careflux H70;Careflux V500
- 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.