510(k) Report

Devices descending from K051107

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181352Loop SystemSpry Health, Inc.201910—
+5K180685AS-3XX Series Fingertip Pulse OximeterXiamen Acurio Instruments Co., Ltd.20180—
+5K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+5K163135Finger Pulse OximeterShenzhen Fitfaith Technology Co.,Ltd20174—
+5K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+5K152089Wrist Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+5K160956LD-Oxi systemLd Technology, LLC20162—
+5K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+5K130056Patient MonitorLd Technology, LLC20130—
+6K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+6K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+6K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K240092Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112…Shenzhen Yimi Life Technology Co., Ltd.20240—
+6K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+6K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+6K213984Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)Shenzhen Zhengkang Technology Co., Ltd.20220—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K220351Polso WatchChronisense Medical, Ltd.20220—
+6K203812Oxyfit Pulse OximeterShenzhen Viatom Technology Co., Ltd.20220—
+6K212665Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse…Huizhou Xiaoou Technology Co., Ltd.20221—
+6K213515WesperO2Wesper, Inc.20220—
+6K203854Pulse OximeterShenzhen Hexin Zondan Medical Equipment Co., Ltd.20211—
+6K202324Fingertip Pulse OximeterShenzhen Bsx Technology Electronics Co., Ltd.20200—
+6K202173Pulse OximeterShenzhen AOJ Medical Technology Co., Ltd.20201—
+6K201384Pulse OximeterShenzhen Raysintone Technology Co., Ltd.20200—
+6K200141Oxi-W SystemLd Technology, LLC20201—
+6K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+7K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K253306BioTracker 2.0Biotracker, LLC20260—
+7K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+7K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+7K232520Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B…Shenzhen Smallsignal Technology Co., Ltd.20240—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230277Pulse Oximeter (Model OHT60,OXH78)Cofoe Medical Technology Co., Ltd.20240—
+7K213430Fingertip Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20220—
+8K250515EpiMonitorEmpatica S.r.l.20250—