510(k) K212658

CloudCath Peritoneal Dialysis Drain Set Monitoring System by Cloudcath — Product Code FKX

K212658 is an FDA 510(k) premarket notification submitted by Cloudcath for the device "CloudCath Peritoneal Dialysis Drain Set Monitoring System". The FDA issued a decision of Substantially Equivalent on February 9, 2022. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630.