510(k) Report

Devices descending from K021090

426 later devices reach Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+6K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+6K124041NBM-200MPOrsense, Ltd.20131—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+6K121424Expression Information PortalInvivo Corporation201224
+6K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K214115MightySat -OTCMasimo Corporation20241—
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+7K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K191882Masimo Centroid SystemMasimo Corporation20203—
+7K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+7K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+7K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+7K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+7K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+7K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+7K160746CARDIOLINE touchECGCardioline S.P.A20160—
+7K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+7K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+7K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+7K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+7K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+7K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+7K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+7K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+8K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+8K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+8K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+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—
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K241397HinscopeHinlab Sas20240—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+8K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+8K240251ANNE ChestSibel Health, Inc.20240—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+8K223721Masimo StorkMasimo Corporation20230—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K223498Radius VSM and AccessoriesMasimo Corporation202312
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K213911Microstream CO2 NanoPodCovidien, LLC20220—
+8K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—