510(k) Report

Devices descending from K952474

350 later devices reach Eagle 3000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+8K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+8K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+8K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+8K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+8K202375ZOLL Propaq MZOLL Medical Corporation20211—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+8K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+8K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+8K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+8K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+8K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+8K172890SedLine Sedation MonitorMasimo Corporation20185—
+8K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+8K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+8K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+8K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+8K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+8K161909IQvitals ZoneMidmark Corporation201614
+8K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+8K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+8K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+8K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+8K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+8K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+8K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+8K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+8K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+8K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+8K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+8K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+9K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+9K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+9K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+9K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+9K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+9K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+9K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+9K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+9K213911Microstream CO2 NanoPodCovidien, LLC20220—
+9K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+9K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+9K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+9K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+9K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+9K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+9K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+9K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+9K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+9K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+9K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+9K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+9K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+10K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+10K260880SedLine Sedation MonitorMasimo Corporation20260—
+10K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+10K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+10K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+10K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+10K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K241397HinscopeHinlab Sas20240—
+10K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+10K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+10K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+10K222550Current Health SystemCurrent Health, Ltd.20221—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+10K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+10K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+10K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+10K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521