510(k) Report

Devices descending from K053130

59 later devices reach Onyx II Finger Pulse Oximeter, Model 9550 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112843Pulse OximeterNonin Medical, Inc.201227—
+1K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+2K193350Leadtek Fingertip Pulse OximeterLeadtek Research, Inc.20204—
+2K163382Oxitone 1000Oxitone Medical, Ltd.201717—
+2K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+2K131021Pulse OximeterNonin Medical, Inc.20133—
+2K113865PultolSharp Corporation20120—
+2K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+3K252448AViTA Pulse Oximeter (SP61)Avita Corporation20260—
+3K223399AViTA Pulse OximeterAvita Corporation20241—
+3K210032Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)Leadtek Research, Inc.20210—
+3K191403Pulse OximeterNonin Medical, Inc.20191—
+3K183556oCare Wrist Pulse OximeterTaiwan Biophotonic Corporation20190—
+3K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+3K181006BB-613 Watch OximeterBio-Beat Technologies, Ltd.201815—
+3K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+3K140785Pulse OximeterNonin Medical, Inc.20140—
+3K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+4K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+4K242455AViTA Pulse Oximeter (SP62B)Avita Corporation20250—
+4K241090Evie Med RingMovano Inc. Dba Movano Health20240—
+4K231288VyvoVyvo Technology Corp.(Vt)20240—
+4K214115MightySat -OTCMasimo Corporation20241—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+4K211632Pulse 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—
+4K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+4K190792BB-613WPBiobeat Technologies, Ltd.201912—
+4K181352Loop SystemSpry Health, Inc.201910—
+4K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+4K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+5K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+5K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+5K232445CSF-4 (CSF-4)Cardiacsense20240—
+5K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+5K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+5K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+5K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+5K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K220351Polso WatchChronisense Medical, Ltd.20220—
+6K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+6K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+7K250515EpiMonitorEmpatica S.r.l.20250—