510(k) Report

Devices descending from K911598

269 later devices reach Datascope Passport Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+7K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+7K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+7K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+7K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+7K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+7K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+7K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+7K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+7K121367Zoll Propaq XMZOLL Medical Corporation201231
+7K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+7K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+7K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+8K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+8K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+8K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K214115MightySat -OTCMasimo Corporation20241—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+8K213911Microstream CO2 NanoPodCovidien, LLC20220—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+8K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+8K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+8K202336Patient MonitorEdan Instruments, Inc.202131
+8K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+8K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+8K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+8K181352Loop SystemSpry Health, Inc.201910—
+8K180482ZOLL Propaq MZOLL Medical Corporation20182—
+8K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+8K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+8K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+8K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+8K152659V10Mediana Co., Ltd.20162—
+8K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+8K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+8K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+8K142915ZOLL X SeriesZOLL Medical Corporation20140—
+8K141774Zoll X SeriesZOLL Medical Corporation20142—
+8K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+8K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+8K124041NBM-200MPOrsense, Ltd.20131—
+8K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+8K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+8K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+9K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+9K202375ZOLL Propaq MZOLL Medical Corporation20211—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+9K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+9K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+9K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+9K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+9K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+9K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+9K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+9K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+9K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+9K172890SedLine Sedation MonitorMasimo Corporation20185—
+9K170497V10Mediana Co., Ltd.201711
+9K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+9K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+9K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+9K161909IQvitals ZoneMidmark Corporation201614
+9K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+9K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+9K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+9K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+9K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+9K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+9K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+10K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—