510(k) Report

Devices descending from K021422

426 later devices reach Philips Information Center Software Revision D.02 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+5K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K110922Patient MonitorEdan Instruments, Inc.201111
+5K101692Patient MonitorContec Medical System Co., Ltd.201101
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K103686STAR 50 NLarsen & Toubro Limited20111—
+5K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+5K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+5K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+5K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+5K083719LNCS Oximetry SensorsMasimo Corporation20092—
+5K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+5K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+5K090172Star 55 Model 100Larsen & Toubro Limited20090—
+5K083622LNCS Oximetry SensorsMasimo Corporation20091—
+5K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K082685Galaxy 55Larsen & Toubro Limited20080—
+5K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+5K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+5K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+5K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+5K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+5K050128Vitalware VMSTelevital, Inc.20050—
+6K254102GlucommanderGlytec, LLC20260—
+6K253436c-med0 alphaCosinuss GmbH20260—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K232035ImpalaAliveCor, Inc.20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K231625VitalDetectWellvii, Inc.20240—
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+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—
+6K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+6K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+6K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+6K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K200443EndoTool IV 1.10Monarch Medical Technologies, LLC20203—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K180366EndoTool SubQAl Pacheco and Associates20181—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+6K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+6K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+6K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+6K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+6K132033BM3/BM3 PlusNoblitt & Rueland20130—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+6K130056Patient MonitorLd Technology, LLC20130—
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+6K121424Expression Information PortalInvivo Corporation201224
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+6K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+6K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+6K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+6K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+6K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+6K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+6K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—