510(k) Report

Devices descending from K810996

12 later devices reach Enternal Pump Set W/Integral Container through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061432Hospira Enteral Feeding Set, Model 20640Hospira, Inc.200611—
+2K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc.20159Class I
+2K102741Enteral Feeding Bag and SetsShandong Weigao Group Medical Polymer Co., Ltd.20110—
+3K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc.20175Class I
+3K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien201625
+4K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah20260—
+4K223607Plum Duo™ Infusion SystemIcu Medical, Inc.20232Class I
+4K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…Cardinal Health, LLC20220—
+4K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+5K242114Plum Solo™ Precision IV PumpIcu Medical, Inc.202503
+5K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.202502
+5K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—