510(k) Report

Devices descending from K001664

405 later devices reach Compact Portable Patient Monitor with Wireless Alan, Model Alilent… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+6K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+6K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+6K160746CARDIOLINE touchECGCardioline S.P.A20160—
+6K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+6K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+6K140430740 SelectCas Medical Systems, Inc.20141—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K121912E1 Ear SensorsMasimo Corporation20124—
+6K121424Expression Information PortalInvivo Corporation201224
+6K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+6K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+6K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+7K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+7K260008Deterioration Index Version 2Epic Systems Corporation20260—
+7K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+7K251326Respiration Rate algorithmEdwards Lifesciences, 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—
+7K241397HinscopeHinlab Sas20240—
+7K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+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—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+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
+7K230415Cadwell GuardianCadwell Industries, Inc.20230—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K221203AHI SystemFifth Eye, Inc.20220—
+7K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.20220—
+7K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K192595ExSpiron 2XiRespiratory Motion20190—
+7K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+7K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+7K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+7K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K150620740 SelectCas Medical Systems, Inc.201501
+7K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+7K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+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—
+8K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+8K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+8K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+8K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+8K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+8K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K213515WesperO2Wesper, Inc.20220—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K202851Spo2 SensorJkh USA, LLC20201—
+8K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+8K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+8K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+8K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+8K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+8K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+8K173045OximeterShenzhen Greatmade Tech Limited20180—
+8K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—