510(k) Report

Devices descending from K010924

14 later devices reach Modification to Plum XL Infusion Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii…Alaris Medical Systems, Inc.200113Class I
+2K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc.20143Class I
+2K090087Mridium 3860 Mri Infusion Pump/Monitoring SystemIradimed Corporation20092Class I
+2K050301Mridium 3850 Mri Pump SystemIradimed Corporation200542
+2K030136Drip AlertDrip Alert, Inc.20033—
+3K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.20231Class I
+3K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG20220—
+3K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation201611
+3K150687DripAssistShift Labs20151—
+3K133870Fluid Level MonitorColeman Laboratories20140—
+3K073051Medrad Continuum MR Infusion System with Wireless Remote AccessoryMedrad, Inc.200802
+4K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation20250—
+4K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.20250—
+4K172242DripAssist PlusShift Labs, Inc.20180—