About This 510(k) Submission
K220935 is an FDA 510(k) clearance for the Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App, a System, Peritoneal, Automatic Delivery (Class II — Special Controls, product code FKX), submitted by Iren-Medical, Ltd. (Or Aquiva, IL). The FDA issued a Cleared decision on December 29, 2022, 273 days after receiving the submission on March 31, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.