510(k) K231125

2008T BlueStar Hemodialysis Machine by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K231125 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "2008T BlueStar Hemodialysis Machine". The FDA issued a decision of Substantially Equivalent on December 6, 2023. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.