510(k) Report

Devices descending from K990966

477 later devices reach Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+7K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+7K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+7K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+7K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+7K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+7K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+8K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+8K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+8K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+8K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+8K213169BPAP SystemBMC Medical Co., Ltd.20220—
+8K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+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—
+8K202970Ventway SparrowInovytech Medical Solutions, Ltd.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—
+8K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+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—
+8K161450Hamilton-C3Hamilton Medical AG201732
+8K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+8K161492Juno VPAP ST-AResmed, Ltd.20171—
+8K160481Vivo 60Breas Medical AB201672
+8K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+8K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+8K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+8K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+8K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+8K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+8K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+8K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+8K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+8K131774Hamilton-G5Hamilton Medical AG201310Class I
+8K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+8K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+8K103803Hamilton-G5Hamilton Medical AG201114Class I
+8K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+8K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+8K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+8K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+8K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+9K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+9K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+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—
+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—
+9K201306Hamilton-C3Hamilton Medical AG20210Class I
+9K201658Hamilton-C6Hamilton Medical AG20201Class I
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+9K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+9K180295Hamilton-G5Hamiton Medical AG20192—
+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
+9K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+9K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+9K153688Edi Catheter ENFitMaquet Critical Care AB201711
+9K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+9K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+9K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+9K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—