510(k) Report

Devices descending from K991823

785 later devices reach N-395 Pulse Oximeter, Model N-395 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+8K240756Aitrics-VCAitrics Co., Ltd.20240—
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+8K240251ANNE ChestSibel Health, Inc.20240—
+8K240305ANNE LimbSibel Health, Inc.20240—
+8K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+8K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+8K223578T3 Platform softwareEtiometry, Inc.20232—
+8K223498Radius VSM and AccessoriesMasimo Corporation202312
+8K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+8K213423T3 Platform softwareEtiometry, Inc.20232—
+8K222463EchoGo Heart FailureUltromics Limited20227—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+8K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+8K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+8K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+8K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+8K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+8K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+8K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+8K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+8K173181ExSpiron 1XiRespiratory Motion, Inc.20182—
+8K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+8K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+8K163584M3290B Philips IntelliVue Information Center iXPhilips Medical Systems20172—
+8K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+8K160746CARDIOLINE touchECGCardioline S.P.A20160—
+8K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+8K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+8K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+8K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+8K121424Expression Information PortalInvivo Corporation201224
+8K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+8K103700Essential Mri Patient MonitorInvivo Corporation20110—
+9K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.20260—
+9K251293CardioVisionIcardio.Ai20250—
+9K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+9K243324Masimo O3 Regional OximeterMasimo Corporation20250—
+9K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+9K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+9K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+9K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K231531Pediarity™Hinlab, Inc.20230—
+9K223721Masimo StorkMasimo Corporation20230—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K223905Vivio® LVEDP SystemAvicena, LLC20230—
+9K231335Cleerly ISCHEMIACleerly, Inc.20230—
+9K231276SmartCardia 7L PlatformSmartcardia SA20230—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+9K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+9K212227Philips MR Patient Care PortalInvivo Corporation202101
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+9K192595ExSpiron 2XiRespiratory Motion20190—
+9K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+9K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+9K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+10K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K254066Etiometry PlatformEtiometry, Inc.20260—
+10K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+10K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K212271smart-syncNorthh Medical GmbH20220—
+10K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—