510(k) Report

Devices descending from K941811

555 later devices reach HP M1175A, M1176A, Component Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+6K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+6K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+6K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+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—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH20181—
+6K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+6K173952Universal SmartECGVectracor, Inc.20181—
+6K173454Multi-parameter Patient Monitor, models C30Shenzhen Comen Medical Instruments Co.,Ltd20180—
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+6K173045OximeterShenzhen Greatmade Tech Limited20180—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.20181—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+6K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+6K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd.20160—
+6K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+6K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+6K152831Spot SkanSkanray Technologies Private Limited20160—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K151512Star 60Skanray Technologies Private Limited20160—
+6K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+6K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+6K141321Glucostabilizer Insulin Dosing CalculatorMedical Decision Network20140—
+6K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+6K122632Guava IICardiocomm Solutions, Inc.20142—
+6K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+6K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+6K113853G+ SystemGlytec, LLC201212—
+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—
+6K112190Patient MonitorMediana Co., Ltd.20110—
+6K112652Suresigns VS2+ -Suresigns VsiPhilips Medical Systems201103
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K101692Patient MonitorContec Medical System Co., Ltd.201101
+6K103686STAR 50 NLarsen & Toubro Limited20111—
+6K102560Reprocessed Pulse Oximeter SensorsSterilmed, Inc.20110—
+6K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+6K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+6K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC20100—
+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—
+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—
+6K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+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—
+6K060143LNCS and SPO2.Com SensorsMasimo Corporation200610—
+6K051212Modification to LNCS Oximetry SensorsMasimo Corporation2005855
+7K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+7K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+7K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+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
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K232035ImpalaAliveCor, Inc.20240—
+7K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+7K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+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—