510(k) Report

Devices descending from K962603

1,002 later devices reach Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+9K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+9K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+9K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+9K091238Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc.200961
+9K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+9K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+9K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+10K260008Deterioration Index Version 2Epic Systems Corporation20260—
+10K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+10K260880SedLine Sedation MonitorMasimo Corporation20260—
+10K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+10K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+10K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+10K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+10K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+10K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+10K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+10K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+10K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+10K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+10K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+10K240756Aitrics-VCAitrics Co., Ltd.20240—
+10K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+10K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+10K230842SignalHF (IM008)Implicity, Inc.20230—
+10K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+10K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+10K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+10K223711ANNE OneSibel Health, Inc.20234—
+10K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+10K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+10K213169BPAP SystemBMC Medical Co., Ltd.20220—
+10K221530ANNE PediatricSibel, Inc.20220—
+10K221203AHI SystemFifth Eye, Inc.20220—
+10K213230T3 Platform SoftwareEtiometry, Inc.202212—
+10K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+10K202375ZOLL Propaq MZOLL Medical Corporation20211—
+10K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+10K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+10K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+10K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+10K191882Masimo Centroid SystemMasimo Corporation20203—
+10K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+10K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+10K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+10K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+10K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+10K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+10K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+10K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+10K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+10K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+10K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+10K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+10K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+10K161450Hamilton-C3Hamilton Medical AG201732
+10K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+10K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+10K161492Juno VPAP ST-AResmed, Ltd.20171—
+10K160481Vivo 60Breas Medical AB201672
+10K160746CARDIOLINE touchECGCardioline S.P.A20160—
+10K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+10K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+10K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+10K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+10K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+10K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+10K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+10K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+10K131774Hamilton-G5Hamilton Medical AG201310Class I
+10K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+10K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+10K121424Expression Information PortalInvivo Corporation201224
+10K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+10K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+10K103803Hamilton-G5Hamilton Medical AG201114Class I
+10K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+10K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+10K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+10K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+10K103700Essential Mri Patient MonitorInvivo Corporation20110—
+10K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+11K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+11K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+11K253417Masimo Root Monitoring SystemMasimo Corporation20260—