510(k) Report

Devices descending from K052160

38 later devices reach Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+1K120774Acuity Central Monitoring Station or Acuity Central Monitoring System, Mobile Acuity LT…Welch Allyn, Inc.20124—
+1K120343Connex WorkstationWelch Allyn, Inc.20127—
+1K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+1K071805Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDatascope Corp.20075—
+1K070204Link to Acuity Clinician NotifierWelch Allyn Protocol, Inc.20070—
+2K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+2K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC20163—
+2K132807Monitoring Station, Connex (R) Central Station (CS)Welch Allyn, Inc.20146—
+2K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+2K113165Mini-MedicAthena Gtx201213—
+2K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+3K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+3K190792BB-613WPBiobeat Technologies, Ltd.201912—
+3K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+3K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+3K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+3K151027zensor systemIntelesens Limited20150—
+3K151006EarlySense Central Display Station (CDS)Earlysense, Ltd.20154—
+3K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+4K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+4K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+4K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+4K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K212622Zyter RPMZyter, Inc.20220—
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20202—
+4K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+5K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+5K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+5K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+5K242842ANNE View, Central HubSibel Health, Inc.20251—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K243837iBSMIorbit Digital Technologies Private Limited20250—