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
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K172226MX40 Release B.07Philips Medical Systems201713—
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K170460Sorin ConnectSorin Group Deutschland GmbH20171—
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+5K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+5K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+5K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+5K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+5K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+5K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+5K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+5K142489Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc.20144—
+5K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+5K132037Vital Signs MonitorMindray North America201432
+5K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+5K132488Zoll Code WriterZOLL Medical Corporation20140—
+5K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc.20141—
+5K131272Siren Epcr SuiteMedusa Medical Technologies, Inc.20140—
+5K131919Zoll Epcr IosZOLL Medical Corporation20130—
+5K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+5K131032Philips Suresigns CentralPhilips Medical Systems20131—
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+5K130170Exspiron 1XIRespiratory Motion, Inc.20134—
+5K130056Patient MonitorLd Technology, LLC20130—
+5K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+5K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+5K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+5K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+5K121424Expression Information PortalInvivo Corporation201224
+5K120132Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems20126—
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+5K111320GlobalcardioCardiocomm Solutions, Inc.20113—
+5K112645Radiforce Large Monitor SystemEizo GmbH20112—
+5K110803Suresigns Vsi Vital Signs MonitorPhilips Medical Systems20111—
+5K111114Suresigns VS2 Vital Signs MonitorPhilips Medical Systems20111—
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+5K110085Vantage View SystemSt Jude Medical20110—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)201013—
+5K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+5K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+5K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd.20091—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K080173STAR 55Larsen & Toubro Limited20085—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K073203Carescape V100Ge Medical Systems Information Technologies200720—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network20072—
+5K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+5K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+5K050128Vitalware VMSTelevital, Inc.20050—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+6K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+6K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+6K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+6K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+6K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20241—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+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—
+6K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC20236—
+6K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+6K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…Edwards Lifesciences, LLC202214—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH20210—
+6K212227Philips MR Patient Care PortalInvivo Corporation202101
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K203635Patient Monitoring CablesJkh USA, LLC20212—
+6K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K202851Spo2 SensorJkh USA, LLC20201—