510(k) Report

Devices descending from K951193

421 later devices reach Clinical Vital Signs Monitor, Model #52STP-E1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+6K223567CNS-2101 Central MonitorNihon Kohden Corporation20232—
+6K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+6K220117ARC Intensive Care Information System (ARC System)Ordinatrum Solutions20230—
+6K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K220058BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202231
+6K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+6K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+6K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.20223—
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+6K192488CO2 Sidestream ModuleBeijing Kingst Commercial & Trade Co., Ltd.20200—
+6K191882Masimo Centroid SystemMasimo Corporation20203—
+6K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+6K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+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—
+6K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+6K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+6K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+6K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+6K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+6K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+6K173715AlertWatch:OBAlertwatch, Inc.20180—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+6K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+6K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+6K160981Patient MonitorEdan Instruments, Inc.201681
+6K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K150992Vios Monitoring SystemVios Medical, Inc.20157—
+6K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+6K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+6K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+6K150620740 SelectCas Medical Systems, Inc.201501
+6K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K133484Zoll X SeriesZoll Medical Corp20141—
+6K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+6K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+6K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+6K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+6K131382Expression MR200 Mri Patient Monitoring System, Expression IP5 Information PortalInvivo Corporation201305
+6K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+6K124061Mri Patient Monitoring System (Model 865214)Invivo Corporation201341
+6K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc.20130—
+6K121367Zoll Propaq XMZOLL Medical Corporation201231
+6K121424Expression Information PortalInvivo Corporation201224
+6K120631Patient MonitorAdvanced Instruments, Inc.20120—
+6K103700Essential Mri Patient MonitorInvivo Corporation20110—
+6K094012CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc.201093—
+6K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation2009155—
+7K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+7K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+7K260880SedLine Sedation MonitorMasimo Corporation20260—
+7K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+7K253436c-med0 alphaCosinuss GmbH20260—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+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—
+7K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+7K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+7K241958WARD-CSS (v1.2.x)Ward 24/7 Aps20250—
+7K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+7K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K240756Aitrics-VCAitrics Co., Ltd.20240—
+7K240251ANNE ChestSibel Health, Inc.20240—
+7K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC20240—
+7K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+7K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+7K231625VitalDetectWellvii, Inc.20240—
+7K223498Radius VSM and AccessoriesMasimo Corporation202312
+7K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+7K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+7K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+7K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+7K212227Philips MR Patient Care PortalInvivo Corporation202101
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited202105
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007