510(k) Report

Devices descending from K001930

65 later devices reach Model 8500, Hand Held Pulse Oximeter, Model 8500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061896Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger Clip SP02…Mediaid, Inc.20070—
+1K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc.2005621
+1K033998Masimo Set Rad-5V Pulse Oximeter, Model Rad-5VMasimo Corp.20040—
+2K113165Mini-MedicAthena Gtx201213—
+2K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+2K093853Single-Patient Use Disposable Sensor SeriesNonin Medical, Inc.20102—
+2K093306Single-Patient Use Disposable SensorNonin Medical, Inc.20100—
+2K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+2K083079Quanta Pulse Oximeter, Model: Pulse Link 1000 or QH100Quanta Computer, Inc.20090—
+2K071610Mediaid Pulse Oximeter M30 and M34Mediaid, Inc.20074—
+2K071285Digital Pulse Oximeter, Model 7500Nonin Medical, Inc.200729—
+3K190792BB-613WPBiobeat Technologies, Ltd.201912—
+3K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+3K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+3K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+3K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+3K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+3K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+3K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd.20110—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K100225Pulse Oximeter Model P10Mediana Co., Ltd.20113—
+3K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+3K080255Nonin Medical, Inc., Model 7500 Digital Pulse OximeterNonin Medical, Inc.200810—
+4K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+4K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+4K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+4K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+4K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+4K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+4K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+4K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+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—
+4K202851Spo2 SensorJkh USA, LLC20201—
+4K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+4K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+4K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+4K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+4K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+4K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+4K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+4K173045OximeterShenzhen Greatmade Tech Limited20180—
+4K152659V10Mediana Co., Ltd.20162—
+4K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+4K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+4K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+5K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+5K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+5K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+5K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+5K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K233827OxiWearOxiwear, Inc.20240—
+5K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+5K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+5K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+5K170497V10Mediana Co., Ltd.201711
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001