510(k) K250471

AquaC UNO H by Fresenius Medical Care Renal Therapies Group, LLC — Product Code FIP

K250471 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "AquaC UNO H". The FDA issued a decision of Substantially Equivalent on November 14, 2025. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.