510(k) Report

Devices descending from K103344

10 later devices reach Infusion Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc.20159Class I
+2K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc.20175Class I
+2K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien201625
+3K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah20260—
+3K223607Plum Duo™ Infusion SystemIcu Medical, Inc.20232Class I
+3K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…Cardinal Health, LLC20220—
+3K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+4K242114Plum Solo™ Precision IV PumpIcu Medical, Inc.202503
+4K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.202502
+4K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—