510(k) Report

Devices descending from K982255

816 later devices reach Model 2000 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+8K221530ANNE PediatricSibel, Inc.20220—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K213230T3 Platform SoftwareEtiometry, Inc.202212—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K202375ZOLL Propaq MZOLL Medical Corporation20211—
+8K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+8K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+8K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+8K191882Masimo Centroid SystemMasimo Corporation20203—
+8K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+8K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+8K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.201915—
+8K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+8K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+8K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+8K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+8K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+8K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+8K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+8K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+8K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+8K160746CARDIOLINE touchECGCardioline S.P.A20160—
+8K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+8K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+8K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+8K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+8K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+8K124041NBM-200MPOrsense, Ltd.20131—
+8K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+8K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+8K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+8K121424Expression Information PortalInvivo Corporation201224
+8K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+8K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+8K103700Essential Mri Patient MonitorInvivo Corporation20110—
+9K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+9K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+9K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+9K243837iBSMIorbit Digital Technologies Private Limited20250—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K242842ANNE View, Central HubSibel Health, Inc.20251—
+9K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+9K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+9K240251ANNE ChestSibel Health, Inc.20240—
+9K240305ANNE LimbSibel Health, Inc.20240—
+9K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K223578T3 Platform softwareEtiometry, Inc.20232—
+9K223498Radius VSM and AccessoriesMasimo Corporation202312
+9K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+9K213423T3 Platform softwareEtiometry, Inc.20232—
+9K222463EchoGo Heart FailureUltromics Limited20227—
+9K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+9K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+9K212227Philips MR Patient Care PortalInvivo Corporation202101
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+9K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+9K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+9K192595ExSpiron 2XiRespiratory Motion20190—
+9K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+9K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+9K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+9K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+9K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+9K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+9K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+9K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+9K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K251293CardioVisionIcardio.Ai20250—
+10K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+10K250757Radius VSM and AccessoriesMasimo Corporation20250—
+10K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+10K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+10K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—