510(k) Report

Devices descending from K960934

511 later devices reach HP M1205A Omnicare Component Monitor System Model 24 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K200717CLEWICU System (ClewICUServer and ClewICUnitor)Clew Medical, Ltd.202112—
+6K201446HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleEdwards Lifesiences, LLC2020271
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+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
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K172226MX40 Release B.07Philips Medical Systems201713—
+6K170460Sorin ConnectSorin Group Deutschland GmbH20171—
+6K162131ExSpiron 1XiRespiratory Motion, Inc.20173—
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+6K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+6K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+6K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+6K143057M3290B Philips IntelliVue Information Center iXPhilips Medical Systems201441
+6K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+6K132488Zoll Code WriterZOLL Medical Corporation20140—
+6K131272Siren Epcr SuiteMedusa Medical Technologies, Inc.20140—
+6K131919Zoll Epcr IosZOLL Medical Corporation20130—
+6K123711Patient MonitorShenzhen Creative Industry Co., Ltd.201313—
+6K131032Philips Suresigns CentralPhilips Medical Systems20131—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K112877Comen Multi-Parameter Patient MonitorGoldway (Us), Inc.20121—
+6K121914Masimo Set USPO2 Pulse Oximetry CableMasimo Corporation201201
+6K121424Expression Information PortalInvivo Corporation201224
+6K120132Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems20126—
+6K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+6K102378Vectraplexecg System with VectraplexamiVectracor, Inc.20112—
+6K111320GlobalcardioCardiocomm Solutions, Inc.20113—
+6K112645Radiforce Large Monitor SystemEizo GmbH20112—
+6K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+6K110803Suresigns Vsi Vital Signs MonitorPhilips Medical Systems20111—
+6K111114Suresigns VS2 Vital Signs MonitorPhilips Medical Systems20111—
+6K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K110287Philips Ecg Leadwire SetPhilips Medical Systems201151
+6K110085Vantage View SystemSt Jude Medical20110—
+6K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+6K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)201013—
+6K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+6K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+6K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd.20091—
+6K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+6K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+6K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+6K080173STAR 55Larsen & Toubro Limited20085—
+6K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+6K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+6K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network20072—
+6K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064—
+6K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+6K050128Vitalware VMSTelevital, Inc.20050—
+6K041815LNCS Oximetry SensorsMasimo Corp.200486—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+7K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+7K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+7K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+7K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.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
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K233216CLEWICU SystemClew Medical, Ltd.20240—
+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—
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+7K212219AHI SystemFifth Eye, Inc.20211—
+7K212003ESSENZ Patient MonitorLivanova Deutschland, GmbH20210—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+7K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K202851Spo2 SensorJkh USA, LLC20201—