510(k) Report

Devices descending from K021389

156 later devices reach Biological Sound Monitor (BSM) Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+2K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+2K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+2K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+2K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+3K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+3K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+3K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+3K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K124041NBM-200MPOrsense, Ltd.20131—
+3K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+3K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+3K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+3K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+4K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+4K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+4K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K161909IQvitals ZoneMidmark Corporation201614
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+4K142915ZOLL X SeriesZOLL Medical Corporation20140—
+4K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+4K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+4K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+5K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+5K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+5K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+5K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+5K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+5K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+5K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K180482ZOLL Propaq MZOLL Medical Corporation20182—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K172890SedLine Sedation MonitorMasimo Corporation20185—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+5K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+5K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+6K202375ZOLL Propaq MZOLL Medical Corporation20211—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+6K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+6K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+7K260880SedLine Sedation MonitorMasimo Corporation20260—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+7K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K241397HinscopeHinlab Sas20240—
+7K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+7K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—