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
+1K130947Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.201310—
+1K070371Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd.200779—
+1K063641PC-60, Non-Invasivepulse OximeterShenzhen Creative Industry Co., Ltd.20072—
+1K053130Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc.200659—
+2K172616Pulse OximeterBeijing Safe Heart Technology, Ltd.20180—
+2K180174Belun RingBelun Technology Company Limited20184—
+2K150093Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E…Shenzhen Creative Industry Co., Ltd.20150—
+2K141105Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20148—
+2K140682Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20143—
+2K131047Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20132—
+2K123871Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20132—
+2K120502PC-60NW Fingertip OximeterShenzhen Creative Industry Co., Ltd.20121—
+2K112843Pulse OximeterNonin Medical, Inc.201227—
+2K101577Modification to:Fingertip Pulse Oximeter, Model MD300C SeriesBeijing Choice Electronic Technololgy Co., Ltd.20102—
+2K093757MD300C1 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.201024—
+2K092652Fingertip Pulse Oximeter, Model MD300CA ND300CABeijing Choice Electronic Technololgy Co., Ltd.20100—
+2K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+2K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+2K073454Fingertip Pulse Oximeter, Model CMS-50CContec Medical System Co., Ltd.200810—
+2K072825Fingertip Pulse Oximeter, Model MD300IBeijing Choice Electronic Technololgy Co., Ltd.200820—
+3K212385YUWELL Finger Pulse OximeterJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20221—
+3K193350Leadtek Fingertip Pulse OximeterLeadtek Research, Inc.20204—
+3K191417Belun RingBelun Technology Company Limited20193—
+3K163382Oxitone 1000Oxitone Medical, Ltd.201717—
+3K161938Fingertip Pulse OximeterXuzhou Yongkang Electronic Science Technology Co., Ltd.20170—
+3K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+3K153021Fingertip Pulse Oximeter A310Amemo, Inc.201617—
+3K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd.20161—
+3K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.20161—
+3K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+3K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+3K151206Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20150—
+3K142687Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20151—
+3K141024External Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20150—
+3K141128Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20141—
+3K131021Pulse OximeterNonin Medical, Inc.20133—
+3K123801Finger Pulse OximeterShenzhen Kingyield Technology Co., Ltd.20130—
+3K121697Fingertip Pulse OximeterAndon Health Co, Ltd.20121—
+3K113865PultolSharp Corporation20120—
+3K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+3K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+3K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+3K082487M-50 Series SPO2 SensorBeijing Choice Electronic Technololgy Co., Ltd.20091—
+3K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC20095—
+3K082789G1B Pulse OximeterGeneral Meditech, Inc.20090—
+3K082641Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd.20089—
+3K081125Wrist Pulse Oximeter MD300WBeijing Choice Electronic Technololgy Co., Ltd.200810—
+4K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+4K252448AViTA Pulse Oximeter (SP61)Avita Corporation20260—
+4K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.20260—
+4K223399AViTA Pulse OximeterAvita Corporation20241—
+4K230415Cadwell GuardianCadwell Industries, Inc.20230—
+4K221798Finger Pulse Oximeter, Model: X1906PShenzhen Changkun Technology Co., Ltd.20230—
+4K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+4K210305Pulse OximeterDongguan Lingxin Technologies Co., Ltd.20210—
+4K211407Belun Ring BLR-100XBelun Technology Company Limited20212—
+4K210032Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)Leadtek Research, Inc.20210—
+4K202776Fingertip pulse oximeterShenzhen Lepu Intelligent Medical Equipment Co., Ltd.20210—
+4K191403Pulse OximeterNonin Medical, Inc.20191—
+4K190869Pulse OximeterShenzhen Aeon Technology Co., Ltd.20194—
+4K183556oCare Wrist Pulse OximeterTaiwan Biophotonic Corporation20190—
+4K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+4K181006BB-613 Watch OximeterBio-Beat Technologies, Ltd.201815—
+4K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+4K173123Pulse OximeterShenzhen Imdk Medical Technology Co., Ltd.201811—
+4K172366Wrist Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20185—
+4K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+4K140582Fingertip Pulse OximeterShenzhen Jumper Medical Equipment Co., Ltd.20146—
+4K140785Pulse OximeterNonin Medical, Inc.20140—
+4K131111Ihealth Fingertip Pulse OximeterAndon Health Co, Ltd.20130—
+4K122046Wrist Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20133—
+4K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+4K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd.20110—
+4K101568Model SB100II Finger Pulse OximeterAtlantean20100—
+4K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC20104—
+5K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…Shenzhen Imdk Medical Technology Co., Ltd.20260—
+5K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+5K242455AViTA Pulse Oximeter (SP62B)Avita Corporation20250—
+5K241090Evie Med RingMovano Inc. Dba Movano Health20240—
+5K234110Belun Ring BLR-200 (BLR-200)Belun Technology Company Limited20240—
+5K240808Pulse Oximeter (WS20A)Hunan Accurate Bio-Medical Technology Co., Ltd.20240—
+5K231288VyvoVyvo Technology Corp.(Vt)20240—
+5K214115MightySat -OTCMasimo Corporation20241—
+5K230587Wrist Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+5K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+5K221361circul™ pro RingBodimetrics, LLC20231—
+5K211143Pulse OximeterShenzhen Brav Electronic Technologies Co., Ltd.20230—
+5K221979Pulse Oximeter (Model C101A2, C101B1, C101A3)Shenzhen Imdk Medical Technology Co., Ltd.20220—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+5K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+5K211632Pulse 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—
+5K210274Fingertip Pulse OximeterZhuhai Linte Medical Instrument Co., Ltd.20210—
+5K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+5K201294Pulse OximeterGuangdong Long Yao Electronic Technology Co., Ltd.20200—
+5K200414Pulse OximeterShenzhen Aeon Technology Co., Ltd.20201—
+5K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+5K191430Pulse OximeterShenzhen Yimi Life-Technology Co., Ltd.20197—
+5K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared…Amzetta Technologies Private Limited20190—
+5K190792BB-613WPBiobeat Technologies, Ltd.201912—