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
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K180017MX40 Release C.01Philips Medical Systems20181—
+5K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+5K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+5K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+5K153335AlertWatch: ORAlertwatch, LLC20161—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+5K150992Vios Monitoring SystemVios Medical, Inc.20157—
+5K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+5K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+5K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+5K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+5K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+5K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+5K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+5K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+5K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+5K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+5K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+5K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+5K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+5K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+6K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+6K260880SedLine Sedation MonitorMasimo Corporation20260—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+6K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K222330The Heart SeatCasana Care, Inc.20230—
+6K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+6K180482ZOLL Propaq MZOLL Medical Corporation20182—
+6K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+6K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+6K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+6K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+6K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+6K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—