510(k) Report

Devices descending from K033296

279 later devices reach Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+1K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+1K100225Pulse Oximeter Model P10Mediana Co., Ltd.20113—
+1K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+1K071526Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc.200871
+1K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083—
+1K070985Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc.20084—
+1K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+1K053269Masimo Set Rad-8 Pulse OximeterMasimo Corporation200583—
+1K050605Spacelabs Medical Multiparameter Module 91496Spacelabs Medical, Inc.200511
+1K042536Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation20052441
+2K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+2K152659V10Mediana Co., Ltd.20162—
+2K150095ReDs Wearable SystemSensible Medical Innovations, Ltd.20151—
+2K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+2K140430740 SelectCas Medical Systems, Inc.20141—
+2K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+2K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+2K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+2K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+2K103142Spacelabs Multi-Parameter ModuleSpacelabs Healthcare, Inc.2011014
+2K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+2K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd.20102—
+2K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+2K092838Masimo Set Rad 8 Pulse Oximeter and Accessories, Model Rad 8Masimo Corporation200938—
+2K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+2K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.20092—
+2K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+2K081035Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon…Osypka Medical, Inc.20083—
+2K062268Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03Philips Medical Systems North America Co.200638—
+2K053477Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation2006226—
+2K051439Lnop Blue Oximetry SensorMasimo Corporation200539—
+3K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+3K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+3K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+3K180479ReDS SystemSensible Medical Innovations, Ltd.20190—
+3K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+3K170497V10Mediana Co., Ltd.201711
+3K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+3K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+3K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+3K152043Diagnostic Station DS20Schiller AG20161—
+3K150620740 SelectCas Medical Systems, Inc.201501
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc.201502
+3K124041NBM-200MPOrsense, Ltd.20131—
+3K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+3K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+3K082242Icon, Model C3Osypka Medical, Inc.20080—
+3K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse…Masimo Corporation20082191
+3K061204Masimo Set Radical 7 Pulse CO-OximeterMasimo Corporation2006225—
+4K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+4K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+4K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+4K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+4K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+4K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+4K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation20190—
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K170182Cardiovit FT-1Schiller AG20170—
+4K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc.20161—
+4K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc.20132—
+4K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+4K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+4K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+4K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+4K101123Nexfin Model 2Bmeye B.V.201054—
+4K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+4K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+4K082052Masimo Rainbow Set Radcheck Pulse CO-Oximeter, Radcheck, Rad 57 Spot CheckMasimo Corporation20086—
+4K081659Rainbow Adhesive CO-Oximetry Sensor, Models RI-25-L, RI-25, RI-20 and RI-20-LMasimo Corporation200841—
+4K063140Rainbow Adhesive CO-Oximetry SensorsMasimo Corporation200644—
+5K241397HinscopeHinlab Sas20240—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K222550Current Health SystemCurrent Health, Ltd.20221—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+5K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorNonin Medical, Inc.20180—
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+5K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc.20140—