510(k) Report

Devices descending from K990125

509 later devices reach HP Viridia Component Monitoring System, Model Rev. K through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+6K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+6K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+6K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+6K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+6K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+6K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+6K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+6K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+6K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+6K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+7K260008Deterioration Index Version 2Epic Systems Corporation20260—
+7K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+7K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+7K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+7K254102GlucommanderGlytec, LLC20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+7K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.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
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.20230—
+7K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+7K230842SignalHF (IM008)Implicity, Inc.20230—
+7K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+7K222330The Heart SeatCasana Care, Inc.20230—
+7K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+7K212975MedWandMedwand Solutions, Inc.20221—
+7K221203AHI SystemFifth Eye, Inc.20220—
+7K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+7K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K201040Bioflux Software IIBiotricity20200—
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K200443EndoTool IV 1.10Monarch Medical Technologies, LLC20203—
+7K192595ExSpiron 2XiRespiratory Motion20190—
+7K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+7K180366EndoTool SubQAl Pacheco and Associates20181—
+7K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+7K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+7K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+7K140430740 SelectCas Medical Systems, Inc.20141—
+7K121912E1 Ear SensorsMasimo Corporation20124—
+7K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+7K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+7K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+8K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+8K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+8K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K241397HinscopeHinlab Sas20240—
+8K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC20210—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K201619EndoTool IV SystemMonarch Medical Technologies, LLC20202—
+8K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+8K150620740 SelectCas Medical Systems, Inc.201501
+8K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+9K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+9K241088EndoTool IV (3.1)Monarch Medical Technologies20241—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K213515WesperO2Wesper, Inc.20220—
+9K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—