510(k) Report

Devices descending from K001020

270 later devices reach 8100 Vital Signs Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+6K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+6K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+6K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+6K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K222330The Heart SeatCasana Care, Inc.20230—
+7K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K212975MedWandMedwand Solutions, Inc.20221—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+7K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+7K180482ZOLL Propaq MZOLL Medical Corporation20182—
+7K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+7K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+7K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+7K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+7K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+7K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+7K142915ZOLL X SeriesZOLL Medical Corporation20140—
+7K141774Zoll X SeriesZOLL Medical Corporation20142—
+7K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+7K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+7K124041NBM-200MPOrsense, Ltd.20131—
+7K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+7K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+7K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+8K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+8K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+8K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+8K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+8K202375ZOLL Propaq MZOLL Medical Corporation20211—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+8K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+8K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+8K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+8K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+8K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+8K172890SedLine Sedation MonitorMasimo Corporation20185—
+8K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+8K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+8K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+8K161909IQvitals ZoneMidmark Corporation201614
+8K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+8K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+8K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+8K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+8K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+8K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+8K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+8K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+8K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+9K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+9K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+9K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+9K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+9K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+9K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+9K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+9K213911Microstream CO2 NanoPodCovidien, LLC20220—
+9K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+9K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+9K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+9K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+9K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+9K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+9K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+9K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+9K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+9K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+9K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+9K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—