510(k) Report

Devices descending from K071285

29 later devices reach Digital Pulse Oximeter, Model 7500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx201017—
+1K080255Nonin Medical, Inc., Model 7500 Digital Pulse OximeterNonin Medical, Inc.200810—
+2K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx20200—
+2K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+2K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+2K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+2K130957WVSM (Wirless Vital Signs Monitor)Athena Gtx20131—
+2K113165Mini-MedicAthena Gtx201213—
+2K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+2K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+3K233827OxiWearOxiwear, Inc.20240—
+3K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+3K190792BB-613WPBiobeat Technologies, Ltd.201912—
+3K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+3K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+4K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+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—
+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—
+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—