510(k) K102936

HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R by Baxter Healthcare Corp — Product Code FKX

K102936 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R". The FDA issued a decision of Substantially Equivalent on March 30, 2011. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.