510(k) Report

Devices descending from K133801

18 later devices reach Baxter Sigma Spectrum Infusion Pump with Master Drug Library through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation20231Class I
+1K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation20189Class I
+1K142374ivWatch Model 400Ivwatch, LLC20155—
+2K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation202501
+2K230665Dose IQ Safety SoftwareBaxter Healthcare Corporation20240—
+2K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation20240Class I
+2K211124Dose IQ Safety SoftwareBaxter Healthcare Corporation20220—
+2K220417Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20223—
+2K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+2K153605ivWatch Model 400Ivwatch, LLC20164—
+3K222048Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20222—
+3K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—
+3K162478ivWatchIvwatch, LLC20163—
+4K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation20231Class I
+4K222212ivWatch Model 400Ivwatch, LLC20220—
+4K192385ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient CableIvwatch, LLC20201—
+5K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation202501
+5K233881ivWatch® Model 400Ivwatch, LLC20240—