510(k) K233798

Moda-flx Hemodialysis System and Cartridge by Diality, Inc. — Product Code KDI

K233798 is an FDA 510(k) premarket notification submitted by Diality, Inc. for the device "Moda-flx Hemodialysis System and Cartridge". The FDA issued a decision of Substantially Equivalent on August 2, 2024. 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. Diality, Inc. has at least 1 other 510(k) clearance on record.