510(k) Report

Devices descending from K040259

312 later devices reach Masimo Set Intellivue Pulse Oximeter Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+8K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+8K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+8K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+8K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+8K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—