510(k) Report

Devices descending from K051079

30 later devices reach Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061110Glucommander PlusCollaborativemed, LLC200616—
+1K060806Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086…Hospira, Inc.200612Class I
+2K103224Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc.201110Class I
+2K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)201013—
+2K083019Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareHospira, Inc.20080Class I
+2K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network20072—
+3K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc.20159Class I
+3K141321Glucostabilizer Insulin Dosing CalculatorMedical Decision Network20140—
+3K113853G+ SystemGlytec, LLC201212—
+3K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+4K152300GlucommanderGlytec, LLC20171—
+4K160673Insulin Algorithms SystemInsulin Algorithms20170—
+4K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc.20175Class I
+4K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…Covidien201625
+4K142918EndoTool SubQMonarch Medical Technologies20152—
+4K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies201481
+5K254102GlucommanderGlytec, LLC20260—
+5K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoah20260—
+5K223607Plum Duo™ Infusion SystemIcu Medical, Inc.20232Class I
+5K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…Cardinal Health, LLC20220—
+5K200443EndoTool IV 1.10Monarch Medical Technologies, LLC20203—
+5K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+5K180366EndoTool SubQAl Pacheco and Associates20181—
+6K242114Plum Solo™ Precision IV PumpIcu Medical, Inc.202503
+6K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.202502
+6K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—
+6K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC20210—
+6K201619EndoTool IV SystemMonarch Medical Technologies, LLC20202—
+7K241088EndoTool IV (3.1)Monarch Medical Technologies20241—
+8K260910EndoTool IV Cloud 1.0Glooko, Inc.20260—