510(k) K210575

HDF Assist Mudule, HDF Infusion Set and Substitution Filter by Nephros — Product Code KDI

K210575 is an FDA 510(k) premarket notification submitted by Nephros for the device "HDF Assist Mudule, HDF Infusion Set and Substitution Filter". The FDA issued a decision of Substantially Equivalent on May 13, 2022. 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. Nephros has at least 8 other 510(k) clearances on record.