510(k) K212522

Lilliput APD System by Fresenius Medical Care Renal Therapies Group, LLC — Product Code FKX

K212522 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "Lilliput APD System". The FDA issued a decision of Substantially Equivalent on April 15, 2022. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care Renal Therapies Group, LLC has at least 10 other 510(k) clearances on record.