About This 510(k) Submission
K250523 is an FDA 510(k) clearance for the Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5), a System, Peritoneal, Automatic Delivery (Class II — Special Controls, product code FKX), submitted by Simergent, LLC (Oklahoma City, US). The FDA issued a Cleared decision on October 2, 2025, 223 days after receiving the submission on February 21, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.