510(k) Report

Devices descending from K822549

1 later device reach CCPD Cycler Set W/5 Pronged Safe Lock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…Simergent, LLC20250—