510(k) Report

Devices descending from K950766

36 later devices reach Sigma 8000 and Sigma 8002 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100705Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC20101Class I
+1K070529Aff (Mark I) Volumetric Infusion PumpDefinitive Medical Technologies, Ltd.200705
+1K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl.200428Class I
+1K030136Drip AlertDrip Alert, Inc.20033—
+2K150687DripAssistShift Labs20151—
+2K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation201418Class I
+2K133870Fluid Level MonitorColeman Laboratories20140—
+2K123049Sapphire Infusion PumpQ Core Medical, Ltd.20137—
+2K130690Z-800 Infusion SystemZyno Medical, LLC20130Class I
+2K093332Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X…Delphi Medical Systems20090—
+3K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation20231Class I
+3K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd.20201Class I
+3K172242DripAssist PlusShift Labs, Inc.20180—
+3K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation20189Class I
+3K171346Sapphire SetsIcu Medical201709
+3K160492Hospira Sapphire SetsHospira, Inc.20160—
+3K142374ivWatch Model 400Ivwatch, LLC20155—
+3K141389Sapphire Infusion PumpQ Core Medical, Ltd.20143—
+3K141834Sapphire Administration SetQ Core Medical, Ltd.20140—
+4K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation202501
+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—
+4K220417Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20223—
+4K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+4K161667Sapphire Infusion PumpQ Core Medical, Ltd.20172—
+4K153605ivWatch Model 400Ivwatch, LLC20164—
+5K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20222—
+5K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—
+5K162478ivWatchIvwatch, LLC20163—
+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—