About This 510(k) Submission
K102936 is an FDA 510(k) clearance for the HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R, a System, Peritoneal, Automatic Delivery (Class II — Special Controls, product code FKX), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 30, 2011, 177 days after receiving the submission on October 4, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.