About This 510(k) Submission
K053512 is an FDA 510(k) clearance for the HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310, 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 February 16, 2006, 62 days after receiving the submission on December 16, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.