510(k) Report

Devices descending from K050301

4 later devices reach Mridium 3850 Mri Pump System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation20092Class I
+1K073051Medrad Continuum MR Infusion System with Wireless Remote AccessoryMedrad, Inc.200802
+2K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation201611
+3K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation20250—