510(k) Report

Devices descending from K001085

197 later devices reach Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113865PultolSharp Corporation20120—
+1K051107Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc.2005154—
+1K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd.20045—
+1K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc.200243—
+2K202483MyHomeDocMyhomedoc, Ltd.20211—
+2K173589PrizmaG-Medical Innovations, Ltd.20180—
+2K170181PrizmaG-Medical Innovations, Ltd.20171—
+2K130947Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.201310—
+2K080375RMX Physiological Data RecorderS.L.P., Ltd.20080—
+2K070371Fingertip Pulse Oximeter MD300CBeijing Choice Electronic Technololgy Co., Ltd.200779—
+2K063641PC-60, Non-Invasivepulse OximeterShenzhen Creative Industry Co., Ltd.20072—
+2K053130Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc.200659—
+2K043528SpirotelMir Medical Intl. Research Srl200542—
+3K223785N9+Nonagon, Ltd.20230—
+3K172616Pulse OximeterBeijing Safe Heart Technology, Ltd.20180—
+3K180174Belun RingBelun Technology Company Limited20184—
+3K150093Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E…Shenzhen Creative Industry Co., Ltd.20150—
+3K141105Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd.20148—
+3K140682Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20143—
+3K130784SpirotelMir Medical Intl. Research Srl20130—
+3K131047Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20132—
+3K123871Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20132—
+3K120502PC-60NW Fingertip OximeterShenzhen Creative Industry Co., Ltd.20121—
+3K112843Pulse OximeterNonin Medical, Inc.201227—
+3K101577Modification to:Fingertip Pulse Oximeter, Model MD300C SeriesBeijing Choice Electronic Technololgy Co., Ltd.20102—
+3K093757MD300C1 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.201024—
+3K092652Fingertip Pulse Oximeter, Model MD300CA ND300CABeijing Choice Electronic Technololgy Co., Ltd.20100—
+3K081712Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700Guangdong Biolight Meditech Co., Ltd.20083—
+3K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+3K073454Fingertip Pulse Oximeter, Model CMS-50CContec Medical System Co., Ltd.200810—
+3K072825Fingertip Pulse Oximeter, Model MD300IBeijing Choice Electronic Technololgy Co., Ltd.200820—
+3K061712Spirobank IIMir Medical Intl. Research Srl200640—
+4K212385YUWELL Finger Pulse OximeterJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20221—
+4K193350Leadtek Fingertip Pulse OximeterLeadtek Research, Inc.20204—
+4K191417Belun RingBelun Technology Company Limited20193—
+4K163382Oxitone 1000Oxitone Medical, Ltd.201717—
+4K161938Fingertip Pulse OximeterXuzhou Yongkang Electronic Science Technology Co., Ltd.20170—
+4K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+4K153021Fingertip Pulse Oximeter A310Amemo, Inc.201617—
+4K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd.20161—
+4K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.20161—
+4K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech Co., Ltd.20160—
+4K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+4K151206Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20150—
+4K142687Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20151—
+4K141024External Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20150—
+4K141128Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20141—
+4K131021Pulse OximeterNonin Medical, Inc.20133—
+4K123801Finger Pulse OximeterShenzhen Kingyield Technology Co., Ltd.20130—
+4K121697Fingertip Pulse OximeterAndon Health Co, Ltd.20121—
+4K112804Fingertip Pulse OximeterGuangdong Biolight Meditech Co., Ltd.20120—
+4K103530SpirodocMedical International Research USA, Inc.20114—
+4K101694Handheld Pulse Oximeter Model M800Guangdong Biolight Meditech Co., Ltd.20100—
+4K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+4K082487M-50 Series SPO2 SensorBeijing Choice Electronic Technololgy Co., Ltd.20091—
+4K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC20095—
+4K081033MiroxiMir Medical Intl. Research Srl20090—
+4K082789G1B Pulse OximeterGeneral Meditech, Inc.20090—
+4K082641Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd.20089—
+4K081125Wrist Pulse Oximeter MD300WBeijing Choice Electronic Technololgy Co., Ltd.200810—
+4K072979Spirobank GMir Medical Intl. Research Srl200733—
+5K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+5K252448AViTA Pulse Oximeter (SP61)Avita Corporation20260—
+5K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.20260—
+5K223399AViTA Pulse OximeterAvita Corporation20241—
+5K231416Air Next (NVD-02)Nuvoair AB20240—
+5K230501Spirobank OxiMir Medical International Research USA20230—
+5K230415Cadwell GuardianCadwell Industries, Inc.20230—
+5K221798Finger Pulse Oximeter, Model: X1906PShenzhen Changkun Technology Co., Ltd.20230—
+5K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+5K210305Pulse OximeterDongguan Lingxin Technologies Co., Ltd.20210—
+5K211407Belun Ring BLR-100XBelun Technology Company Limited20212—
+5K210032Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)Leadtek Research, Inc.20210—
+5K202776Fingertip pulse oximeterShenzhen Lepu Intelligent Medical Equipment Co., Ltd.20210—
+5K201002Safey Pocket SpirometerSafey Medical Devices Pvt, Ltd.20200—
+5K183089Air NextNuvoair AB20201—
+5K191403Pulse OximeterNonin Medical, Inc.20191—
+5K190869Pulse OximeterShenzhen Aeon Technology Co., Ltd.20194—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+5K183556oCare Wrist Pulse OximeterTaiwan Biophotonic Corporation20190—
+5K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+5K181006BB-613 Watch OximeterBio-Beat Technologies, Ltd.201815—
+5K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+5K173123Pulse OximeterShenzhen Imdk Medical Technology Co., Ltd.201811—
+5K172366Wrist Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20185—
+5K170798Dictum HealthDictum Health, Inc.20175—
+5K163249GoSpiroMonitored Therapeutics, Inc.20172—
+5K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+5K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd.20142—
+5K140582Fingertip Pulse OximeterShenzhen Jumper Medical Equipment Co., Ltd.20146—
+5K140785Pulse OximeterNonin Medical, Inc.20140—
+5K131111Ihealth Fingertip Pulse OximeterAndon Health Co, Ltd.20130—
+5K122046Wrist Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20133—
+5K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+5K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd.20110—
+5K101568Model SB100II Finger Pulse OximeterAtlantean20100—
+5K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC20104—
+5K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+6K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…Shenzhen Imdk Medical Technology Co., Ltd.20260—
+6K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—