510(k) Report

Devices descending from K922974

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K120631Patient MonitorAdvanced Instruments, Inc.20120—
+7K113853G+ SystemGlytec, LLC201212—
+7K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+7K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+7K112190Patient MonitorMediana Co., Ltd.20110—
+7K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+7K112652Suresigns VS2+ -Suresigns VsiPhilips Medical Systems201103
+7K110723M-LNCS Oximetry Sensors, Reprocessed M-LNCS Oximetry SensorsMasimo Corporation20110—
+7K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG2010312
+7K101031Masimo Disposable Oximetry Ear Sensor, Model E1Masimo Corporation20105—
+7K101896Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation201062—
+7K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+7K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+7K100617Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20DMasimo Corporation201039—
+7K094046LNCS Oximetry Sensors, Reprocessed LNCS Oximetry SensorsMasimo Corporation20100—
+7K090662Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ DbipMasimo Corporation200911
+7K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+8K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+8K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.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—
+8K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+8K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+8K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+8K241397HinscopeHinlab Sas20240—
+8K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+8K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+8K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG20240—
+8K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K203635Patient Monitoring CablesJkh USA, LLC20212—
+8K201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.20200—
+8K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+8K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+8K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+8K191018Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive SensorsSurgical Instrument Service and Savings, Inc.20190—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+8K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+8K152300GlucommanderGlytec, LLC20171—
+8K160673Insulin Algorithms SystemInsulin Algorithms20170—
+8K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+8K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+8K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG20170—
+8K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd.20160—
+8K162571Bioflux SoftwareBiotricity, Inc.20161—
+8K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+8K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG201519
+8K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+8K142918EndoTool SubQMonarch Medical Technologies20152—
+8K140430740 SelectCas Medical Systems, Inc.20141—
+8K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies201481
+8K121912E1 Ear SensorsMasimo Corporation20124—
+8K113596Masimo Set Reusable Oximetry SensorsMasimo Corporation20120—
+8K111621Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry SensorsMasimo Corporation201138—
+8K111888Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation201159—
+9K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+9K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+9K254102GlucommanderGlytec, LLC20260—
+9K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+9K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…Physio-Control, Inc.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.20230—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+9K201040Bioflux Software IIBiotricity20200—
+9K200443EndoTool IV 1.10Monarch Medical Technologies, LLC20203—
+9K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+9K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K180366EndoTool SubQAl Pacheco and Associates20181—
+9K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K150620740 SelectCas Medical Systems, Inc.201501
+9K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—