510(k) Report

Devices descending from K031740

290 later devices reach VSM - Vital Signs Monitor, Model 53000 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+4K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K180017MX40 Release C.01Philips Medical Systems20181—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+4K172890SedLine Sedation MonitorMasimo Corporation20185—
+4K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+4K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+4K171322eCareManager 4.1Visicu, Inc.20172—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+4K153335AlertWatch: ORAlertwatch, LLC20161—
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+4K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+4K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+4K142106Decisio Health Patient DashboardDecisio Health, Inc.20155—
+4K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+4K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+4K140535Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50Philips Medizin Systeme Boblingen GmbH201405
+4K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K113653Patient MonitorEdan Instruments, Inc.201212
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+4K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+4K103285Dixtal DZ-4100 Series Pulse OximeterDixtal Medical, Inc.20110—
+4K101449Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201092—
+4K090785Mri Compatible Patient Monitoring System, Model 865214Invivo Corp.200996
+5K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.20260—
+5K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+5K242962Telemetry Monitor 5500 Release 4.0 (867232)Philips Medizin Systeme Böblingen GmbH202501
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+5K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+5K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+5K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+5K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+5K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+5K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K211046eCareManager 4.5Visicu, Inc.20220—
+5K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+5K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+5K210160AlertWatch:ACAlertwatch, Inc.20210—
+5K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+5K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+5K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+5K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+5K173715AlertWatch:OBAlertwatch, Inc.20180—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+5K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+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—
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+5K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+5K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+5K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+5K121424Expression Information PortalInvivo Corporation201224
+5K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+6K260880SedLine Sedation MonitorMasimo Corporation20260—
+6K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+6K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+6K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+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—
+6K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+6K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+6K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+6K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+6K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+6K240756Aitrics-VCAitrics Co., Ltd.20240—
+6K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+6K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K212227Philips MR Patient Care PortalInvivo Corporation202101