510(k) Report

Devices descending from K042121

28 later devices reach Spectrum and Spectrum with Master Drug Library through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation201418Class I
+1K123049Sapphire Infusion PumpQ Core Medical, Ltd.20137—
+1K093332Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X…Delphi Medical Systems20090—
+2K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation20231Class I
+2K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd.20201Class I
+2K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation20189Class I
+2K171346Sapphire SetsIcu Medical201709
+2K160492Hospira Sapphire SetsHospira, Inc.20160—
+2K142374ivWatch Model 400Ivwatch, LLC20155—
+2K141389Sapphire Infusion PumpQ Core Medical, Ltd.20143—
+2K141834Sapphire Administration SetQ Core Medical, Ltd.20140—
+3K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation202501
+3K230665Dose IQ Safety SoftwareBaxter Healthcare Corporation20240—
+3K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation20240Class I
+3K213744Avoset Infusion Pump SystemEitan Medical, Ltd.20230—
+3K211124Dose IQ Safety SoftwareBaxter Healthcare Corporation20220—
+3K220417Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20223—
+3K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+3K161667Sapphire Infusion PumpQ Core Medical, Ltd.20172—
+3K153605ivWatch Model 400Ivwatch, LLC20164—
+4K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20222—
+4K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—
+4K162478ivWatchIvwatch, LLC20163—
+5K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20231Class I
+5K222212ivWatch Model 400Ivwatch, LLC20220—
+5K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC20201—
+6K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation202501
+6K233881ivWatch® Model 400Ivwatch, LLC20240—