510(k) Report

Devices descending from K051608

259 later devices reach Star 50 Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222330The Heart SeatCasana Care, Inc.20230—
+6K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+6K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+6K180482ZOLL Propaq MZOLL Medical Corporation20182—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+6K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+6K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+6K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+6K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+6K124041NBM-200MPOrsense, Ltd.20131—
+6K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+6K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+6K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+7K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+7K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+7K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+7K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+7K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+7K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+7K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+7K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+7K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+7K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+7K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+7K172890SedLine Sedation MonitorMasimo Corporation20185—
+7K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+7K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+7K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+7K161909IQvitals ZoneMidmark Corporation201614
+7K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+7K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+7K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+7K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+7K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+7K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+7K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+7K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+7K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+8K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+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—
+8K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+8K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+8K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+8K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+8K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+8K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+8K213911Microstream CO2 NanoPodCovidien, LLC20220—
+8K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+8K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+8K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+8K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+8K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+8K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+8K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+8K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+8K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+8K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+8K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+8K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+9K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+9K260880SedLine Sedation MonitorMasimo Corporation20260—
+9K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+9K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+9K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+9K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+9K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+9K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+9K241397HinscopeHinlab Sas20240—
+9K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—