510(k) Report

Devices descending from K030459

73 later devices reach Medley System with Medication Management System (MMS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc.20143Class I
+1K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Smiths Medical MD, Inc.20114Class I
+1K072105Alaris System with MMS, Model 8XXXCardinal Health 303,Inc.20074Class I
+1K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc.200615Class I
+1K062699Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc.20064—
+1K043590SE Infusion System with MMSCardinal Health, Alaris Products200501
+1K042609Hospira Mednet Medication Management SuiteHospira, Inc.200441
+1K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl.200428Class I
+1K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc.20047Class I
+2K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.20231Class I
+2K211125Novum IQ Syringe PumpBaxter Healthcare Corporation20221Class I
+2K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG20220—
+2K191910SpaceStation MRIB. Braun Melsugen AG20200Class I
+2K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc.201804
+2K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+2K140838IV Administration Set with Hand PumpB.Braun Medical, Inc.20146—
+2K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc.20141Class I
+2K141102Hospira Mednet Medication Management SuiteHospira, Inc.201432
+2K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation201418Class I
+2K123049Sapphire Infusion PumpQ Core Medical, Ltd.20137—
+2K121613Agilia Infusion SystemFresenius Kabi AG20132Class I
+2K111381Medi-Sis Syringe Infusion SystemAcacia, Inc.20120—
+2K101439Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc.20111—
+2K093332Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X…Delphi Medical Systems20090—
+2K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc.200914
+2K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc.20094Class I
+2K050883Safersleep SystemSafer Sleep, LLC20056—
+3K243392Infusomat® Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc.20250—
+3K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…Codonics.Incorporated20250—
+3K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.20250—
+3K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation20240Class I
+3K223606LifeShield™ Infusion Safety Software SuiteIcu Medical, Inc.202321
+3K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation20231Class I
+3K210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG20220—
+3K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…Fresenius Kabi AG20220—
+3K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd.20201Class I
+3K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation20189Class I
+3K170595IV Administration SetsB.Braun Medical, Inc.2017319
+3K171346Sapphire SetsIcu Medical201709
+3K160492Hospira Sapphire SetsHospira, Inc.20160—
+3K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+3K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC20161—
+3K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc.20150Class I
+3K142374ivWatch Model 400Ivwatch, LLC20155—
+3K141389Sapphire Infusion PumpQ Core Medical, Ltd.20143—
+3K141834Sapphire Administration SetQ Core Medical, Ltd.20140—
+3K062388Anesthesia Information and Digital-Drug Management SystemDocusys20075—
+4K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation202501
+4K242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc.202512
+4K230665Dose IQ Safety SoftwareBaxter Healthcare Corporation20240—
+4K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation20240Class I
+4K213744Avoset Infusion Pump SystemEitan Medical, Ltd.20230—
+4K211124Dose IQ Safety SoftwareBaxter Healthcare Corporation20220—
+4K213588Q2 IV Administration SetsQuest Medical, Inc.20220—
+4K220417Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20223—
+4K202618IV Administration SetsB.Braun Medical, Inc.202101
+4K191362LifeFlow Blood System410 Medical, Inc.20200—
+4K191658IV Sets not made with PVCB.Braun Medical, Inc.202001
+4K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+4K161667Sapphire Infusion PumpQ Core Medical, Ltd.20172—
+4K153605ivWatch Model 400Ivwatch, LLC20164—
+4K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO201421
+5K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc.20260—
+5K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20222—
+5K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—
+5K182092BD Intelliport SystemBecton, Dickinson and Company20191—
+5K162478ivWatchIvwatch, LLC20163—
+6K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229)…Becton Dickinson20250—
+6K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20231Class I
+6K222212ivWatch Model 400Ivwatch, LLC20220—
+6K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC20201—
+7K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation202501
+7K233881ivWatch® Model 400Ivwatch, LLC20240—