510(k) Report

Devices descending from K012383

13 later devices reach Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc.20143Class I
+1K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation20092Class I
+1K050301Mridium 3850 Mri Pump SystemIradimed Corporation200542
+1K030136Drip AlertDrip Alert, Inc.20033—
+2K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.20231Class I
+2K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG20220—
+2K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation201611
+2K150687DripAssistShift Labs20151—
+2K133870Fluid Level MonitorColeman Laboratories20140—
+2K073051Medrad Continuum MR Infusion System with Wireless Remote AccessoryMedrad, Inc.200802
+3K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation20250—
+3K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.20250—
+3K172242DripAssist PlusShift Labs, Inc.20180—