510(k) Report

Devices descending from K060806

12 later devices reach Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc.201110Class I
+1K083019Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc.20080Class I
+2K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc.20159Class I
+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—