510(k) Report

Devices descending from K882609

504 later devices reach Models M1175A & M1176A Component Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd.20160—
+6K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc.201601
+6K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+6K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+6K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+6K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2015142
+6K132229Omni Patent MonitorsInfinium Medical20142—
+6K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+6K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+6K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+6K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+6K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K101692Patient MonitorContec Medical System Co., Ltd.201101
+6K103686STAR 50 NLarsen & Toubro Limited20111—
+6K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+6K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+6K102004Endeavour Monitoring SystemMindray DS USA, Inc.201033
+6K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+6K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.201016—
+6K092970General Patient Monitors, Models: G3C/ G3D/ G3F/ G3G/ G3HGeneral Meditech, Inc.20100—
+6K092727H100B Pulse OximeterEdan Instruments, Inc.20090—
+6K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+6K092368Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20090—
+6K083719LNCS Oximetry SensorsMasimo Corporation20092—
+6K090599MD300K1 Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20099—
+6K090671Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DContec Medical System Co., Ltd.20093—
+6K090172Star 55 Model 100Larsen & Toubro Limited20090—
+6K083622LNCS Oximetry SensorsMasimo Corporation20091—
+6K082888Infinity Nellcor Oximax Smartpod, Model MS23997Draeger Medical Systems, Inc.20080—
+6K082685Galaxy 55Larsen & Toubro Limited20080—
+6K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+6K081238Reprocessed Masimo Pulse Oximeter SensorsAscent Healthcare Solutions20083—
+6K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc.20081—
+6K063055VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200613—
+6K060281VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200616—
+6K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+6K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd.200648—
+6K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+7K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+7K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K232035ImpalaAliveCor, Inc.20240—
+7K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K231625VitalDetectWellvii, Inc.20240—
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+7K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.20230—
+7K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+7K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+7K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+7K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+7K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…Stryker Sustainability Solutions20222—
+7K212271smart-syncNorthh Medical GmbH20220—
+7K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+7K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+7K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+7K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+7K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2017121
+7K152043Diagnostic Station DS20Schiller AG20161—
+7K152563Pulse Oximeter (MD300M/MD300K2)Beijing Choice Electronic Technology Co., Ltd.20168—
+7K153079Axeo 3 Patient MonitorAxeo Medical Technologies, LLC20160—
+7K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+7K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+7K150620740 SelectCas Medical Systems, Inc.201501
+7K141362Pulse Oximeter CMS50EWContec Medical Systems Co.,Ltd20151—
+7K142244Cleo Patient MonitorInfinium Medical201501
+7K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+7K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+7K132026V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21Mindray DS USA, Inc.201321
+7K132033BM3/BM3 PlusNoblitt & Rueland20130—
+7K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+7K130056Patient MonitorLd Technology, LLC20130—