510(k) Report

Devices descending from K012891

548 later devices reach Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+5K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+5K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+5K130401Alertwatch: orAlertwatch, LLC20148—
+5K120984Masimo Ras-125C Acoustic Respiration SensorMasimo Corporation20132—
+5K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems201352
+5K130056Patient MonitorLd Technology, LLC20130—
+5K123472Cimva UniversalTherapeutic Monitoring Systems (Tms), Inc.20130—
+5K120657Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsMasimo Corporation201237—
+5K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+5K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+5K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+5K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+5K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+5K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+5K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+5K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+5K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+5K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+5K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+6K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K233827OxiWearOxiwear, Inc.20240—
+6K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+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—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+6K222330The Heart SeatCasana Care, Inc.20230—
+6K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+6K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+6K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+6K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K212975MedWandMedwand Solutions, Inc.20221—
+6K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+6K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+6K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+6K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+6K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+6K180482ZOLL Propaq MZOLL Medical Corporation20182—
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K180017MX40 Release C.01Philips Medical Systems20181—
+6K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+6K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+6K171322eCareManager 4.1Visicu, Inc.20172—
+6K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+6K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+6K153335AlertWatch: ORAlertwatch, LLC20161—
+6K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+6K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+6K150992Vios Monitoring SystemVios Medical, Inc.20157—
+6K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+6K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+6K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+6K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+6K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+6K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+6K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+6K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+6K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+6K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K124041NBM-200MPOrsense, Ltd.20131—
+6K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+6K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+6K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+6K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+6K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+6K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+7K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+7K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+7K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+7K260880SedLine Sedation MonitorMasimo Corporation20260—
+7K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—