510(k) K252181

AquaA by Fresenius Medical Care North America — Product Code FIP

K252181 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "AquaA". The FDA issued a decision of Substantially Equivalent on September 9, 2025. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.