510(k) Report

Devices descending from K033378

108 later devices reach Vital Signs Monitor, Propaq LT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+1K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.2012202
+1K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+1K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+1K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+1K051375Vital Signs MonitorMediana Co., Ltd.20053—
+2K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+2K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+2K152659V10Mediana Co., Ltd.20162—
+2K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+2K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+2K151027zensor systemIntelesens Limited20150—
+2K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+2K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+2K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+2K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+2K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+2K113165Mini-MedicAthena Gtx201213—
+3K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+3K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+3K190792BB-613WPBiobeat Technologies, Ltd.201912—
+3K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+3K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+3K172890SedLine Sedation MonitorMasimo Corporation20185—
+3K170497V10Mediana Co., Ltd.201711
+3K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+3K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+3K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+4K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+4K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+4K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+4K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+4K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+4K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+4K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+4K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+4K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+4K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+4K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+5K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+5K260880SedLine Sedation MonitorMasimo Corporation20260—
+5K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+5K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+5K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+5K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+5K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+5K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+5K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+5K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+6K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K214115MightySat -OTCMasimo Corporation20241—
+6K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+6K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+6K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+6K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+6K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+6K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+6K191882Masimo Centroid SystemMasimo Corporation20203—
+6K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+6K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+6K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+6K181352Loop SystemSpry Health, Inc.201910—
+6K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+7K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+7K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+7K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+7K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+7K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+7K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+7K240251ANNE ChestSibel Health, Inc.20240—
+7K232445CSF-4 (CSF-4)Cardiacsense20240—
+7K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+7K223721Masimo StorkMasimo Corporation20230—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K223498Radius VSM and AccessoriesMasimo Corporation202312
+7K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+7K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+7K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K220351Polso WatchChronisense Medical, Ltd.20220—
+7K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+7K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+7K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+7K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—