510(k) Report

Devices descending from K021778

407 later devices reach Philips Component Compact Monitor, Release a.04, Model #M1275B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+4K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+4K090172Star 55 Model 100Larsen & Toubro Limited20090—
+4K083622LNCS Oximetry SensorsMasimo Corporation20091—
+4K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+4K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+4K082685Galaxy 55Larsen & Toubro Limited20080—
+4K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+4K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+4K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+4K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+4K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+4K050128Vitalware VMSTelevital, Inc.20050—
+5K253436c-med0 alphaCosinuss GmbH20260—
+5K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+5K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+5K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+5K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K240756Aitrics-VCAitrics Co., Ltd.20240—
+5K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+5K232035ImpalaAliveCor, Inc.20240—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+5K231625VitalDetectWellvii, Inc.20240—
+5K233216CLEWICU SystemClew Medical, Ltd.20240—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+5K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+5K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+5K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+5K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+5K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+5K212219AHI SystemFifth Eye, Inc.20211—
+5K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+5K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+5K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+5K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+5K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+5K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+5K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K160746CARDIOLINE touchECGCardioline S.P.A20160—
+5K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+5K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+5K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+5K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+5K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+5K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+5K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+5K132033BM3/BM3 PlusNoblitt & Rueland20130—
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+5K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+5K130056Patient MonitorLd Technology, LLC20130—
+5K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+5K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+5K121424Expression Information PortalInvivo Corporation201224
+5K120631Patient MonitorAdvanced Instruments, Inc.20120—
+5K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+5K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+5K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+5K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+5K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+5K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+5K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+5K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+5K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+5K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+5K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+6K260008Deterioration Index Version 2Epic Systems Corporation20260—
+6K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+6K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+6K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+6K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+6K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—