510(k) Report

Devices descending from K112843

27 later devices reach Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193350Leadtek Fingertip Pulse OximeterLeadtek Research, Inc.20204—
+1K163382Oxitone 1000Oxitone Medical, Ltd.201717—
+1K131021Pulse OximeterNonin Medical, Inc.20133—
+2K252448AViTA Pulse Oximeter (SP61)Avita Corporation20260—
+2K223399AViTA Pulse OximeterAvita Corporation20241—
+2K210032Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)Leadtek Research, Inc.20210—
+2K191403Pulse OximeterNonin Medical, Inc.20191—
+2K183556oCare Wrist Pulse OximeterTaiwan Biophotonic Corporation20190—
+2K181006BB-613 Watch OximeterBio-Beat Technologies, Ltd.201815—
+2K140785Pulse OximeterNonin Medical, Inc.20140—
+3K242455AViTA Pulse Oximeter (SP62B)Avita Corporation20250—
+3K241090Evie Med RingMovano Inc. Dba Movano Health20240—
+3K231288VyvoVyvo Technology Corp.(Vt)20240—
+3K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+3K190792BB-613WPBiobeat Technologies, Ltd.201912—
+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—
+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—