510(k) Report

Devices descending from K922974

511 later devices reach Portable Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K102958Philips Avalon Fetal MonitorPhilips Medizin Systeme Boblingen GmbH20112—
+5K103652Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8Philips Medical Systesms20116—
+5K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+5K102430Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation20106—
+5K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+5K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH20104—
+5K101474MD Vision SystemPerkins Healthcare Technologies20100—
+5K101067Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068Philips Medical Systems201071
+5K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K091572Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200938—
+5K090438Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15…Envitec-Wismar GmbH20090—
+5K091834Passport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division200902
+5K090360Philips M3001A Multi Measurement ServerPhilips Medizin Systeme Boblingen GmbH200984—
+5K090483Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series…Philips Medical Systems2009145
+5K082887PM-1000F+Patient MonitorAdvanced Instrumentations, Inc.20090—
+5K083321Cardio-ViewCurlview Igt, LLC20089—
+5K083228Philips Intellivue MP5 Patient MonitorPhilips Medizin Systeme Boblingen GmbH200885—
+5K082280Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital…Philips Medical Systems North America Co.200811—
+5K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082—
+5K080495Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems2008181
+5K080461Star ST and Arrhythmia Software, Release J.0Philips Medical Systems20086—
+5K080173STAR 55Larsen & Toubro Limited20085—
+5K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd.200819—
+5K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200719—
+5K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Philips Medical Systems, Inc.200741—
+5K062605Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems200646—
+5K062455Philips Adult Reusable SP02 Sensor, Model M1191B, M1191BL, M1191BNLPhilips Medical Systems20060—
+5K061329Infinity Masimo Set SP02 PodDraeger Medical Systems, Inc.200625—
+5K061110Glucommander PlusCollaborativemed, LLC200616—
+5K051366Piconibp Oem ModulePhilips Medizin Systeme Boeblingen GmbH200510—
+5K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH20055—
+5K041815LNCS Oximetry SensorsMasimo Corp.200486—
+5K041741M3290A Intellivue Information Center Software Release F.0 and M4840A Philips Telemetry…Philips Medical Systems, Inc.20041554
+5K033715Picosat II SP02 Pulse Oximetry Module and M3001A Multi-Measurement ServerPhilips Medical Systems, Inc.20041863
+6K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…Philips Medizin Systeme Böblingen GmbH20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+6K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…Unimed Medical Supplies, Inc.20250—
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K233253eCARTv5 Clinical Deterioration Suite (“eCART”)Agilemd, Inc.20241—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K233216CLEWICU SystemClew Medical, Ltd.20240—
+6K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+6K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+6K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC20227—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+6K212219AHI SystemFifth Eye, Inc.20211—
+6K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC20211—
+6K211465HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformEdwards Lfesciences202115—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+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—
+6K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+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—
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+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—
+6K170460Sorin ConnectSorin Group Deutschland GmbH20171—
+6K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+6K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems2016312
+6K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems201601
+6K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation20160—
+6K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+6K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+6K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+6K132488Zoll Code WriterZOLL Medical Corporation20140—
+6K131272Siren Epcr SuiteMedusa Medical Technologies, Inc.20140—
+6K131919Zoll Epcr IosZOLL Medical Corporation20130—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K121424Expression Information PortalInvivo Corporation201224
+6K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+6K120132Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems20126—
+6K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+6K111320GlobalcardioCardiocomm Solutions, Inc.20113—
+6K112645Radiforce Large Monitor SystemEizo GmbH20112—
+6K110922Patient MonitorEdan Instruments, Inc.201111
+6K101692Patient MonitorContec Medical System Co., Ltd.201101