510(k) Report

Devices descending from K993637

715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K113125Intellivue MX40 Patient MonitorPhilips Medical Systems20111416
+6K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+6K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201111
+6K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+6K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+6K101995Capnostream 20P with Masimo SPO2 BoardOridion Capnography, Inc.20117—
+6K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+6K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation2010115—
+6K100939Intellivue Patient Monitor Model: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010123—
+6K081937Picosat II and M3002A Multimeasurement and M1020B Plug-in Modules SPO2 Pulse Oximetry…Philips Medizin Systeme Boeblingen GmbH200849—
+7K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K260880SedLine Sedation MonitorMasimo Corporation20260—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+7K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+7K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+7K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+7K223711ANNE OneSibel Health, Inc.20234—
+7K222330The Heart SeatCasana Care, Inc.20230—
+7K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+7K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+7K221530ANNE PediatricSibel, Inc.20220—
+7K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableEdwards Lifeciences, LLC20226—
+7K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+7K212975MedWandMedwand Solutions, Inc.20221—
+7K213230T3 Platform SoftwareEtiometry, Inc.202212—
+7K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+7K202375ZOLL Propaq MZOLL Medical Corporation20211—
+7K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+7K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC202101
+7K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+7K193391BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2020102
+7K191882Masimo Centroid SystemMasimo Corporation20203—
+7K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+7K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+7K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+7K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC201934—
+7K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+7K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+7K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+7K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+7K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+7K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+7K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+7K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation20180—
+7K180017MX40 Release C.01Philips Medical Systems20181—
+7K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+7K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018291
+7K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+7K171322eCareManager 4.1Visicu, Inc.20172—
+7K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+7K153335AlertWatch: ORAlertwatch, LLC20161—
+7K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+7K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+7K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+7K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+7K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+7K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+7K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+7K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+7K124041NBM-200MPOrsense, Ltd.20131—
+7K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+7K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+7K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+7K110028Masimo Radical Y Pulse CO-OximeterMasimo Corporation201189—
+7K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+7K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+8K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+8K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+8K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+8K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K243837iBSMIorbit Digital Technologies Private Limited20250—
+8K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+8K242842ANNE View, Central HubSibel Health, Inc.20251—
+8K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—