510(k) Report

Devices descending from K013319

124 later devices reach Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041156Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc.2004891
+1K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc.200442—
+2K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+2K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+2K052669Avant Digital Pulse Oximetry System, Model 4000, 4100Nonin Medical, Inc.200511—
+2K0433594100 Patient Oximeter ModuleNonin Medical, Inc.200575—
+2K043162PMP4 Oxy ProCard Guard Scientific Survival, Ltd.20040—
+2K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+3K191574OxSAT 100S.L.P., Ltd.20200—
+3K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+3K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+3K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+3K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20172—
+3K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+3K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+3K120052CvinsightIntelomed, Inc.20120—
+3K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+3K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+3K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+3K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+3K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+3K063814BP-200 PlusSchiller AG20077—
+3K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+4K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+4K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K242290DormoTech NLabDormotech Medical, Ltd.20250—
+4K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+4K222597BabySat 3Owlet Babycare, Inc.20230—
+4K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+4K200537OxxiomTrue Wearables, Inc.20200—
+4K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+4K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+4K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K152831Spot SkanSkanray Technologies Private Limited20160—
+4K151512Star 60Skanray Technologies Private Limited20160—
+4K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+4K143272ApneaLink AirResmed Germany, Inc.20157—
+4K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+4K131379EarlysenseEarlysense, Ltd.20137—
+4K131021Pulse OximeterNonin Medical, Inc.20133—
+4K124062QDC-Pro, and Nox-RipNox Medical20133—
+4K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+4K121617SensicardiacDiacoustic Medical (Pty)201210—
+4K113865PultolSharp Corporation20120—
+4K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+4K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+4K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+5K233827OxiWearOxiwear, Inc.20240—
+5K223721Masimo StorkMasimo Corporation20230—
+5K191403Pulse OximeterNonin Medical, Inc.20191—
+5K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+5K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+5K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+5K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+5K170182Cardiovit FT-1Schiller AG20170—
+5K163665MATRx plusZephyr Sleep Technologies20173—
+5K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+5K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+5K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+5K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K140785Pulse OximeterNonin Medical, Inc.20140—
+5K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+5K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+5K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+5K131287CardiosleeveRijuven Corp20131—
+5K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+6K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+6K253274BedDot (G1)Intelligent Dots, LLC20260—
+6K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+6K242447Falcon HSTCompumedics Limited20250—
+6K214115MightySat -OTCMasimo Corporation20241—
+6K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+6K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+6K211632Pulse 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—
+6K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+6K201299HD StethHd Medical, Inc.20200—
+6K192624ApneaTrakCadwell Industries, Inc.20200—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+6K181988eMurmur IDCsd Labs GmbH20197—
+6K181352Loop SystemSpry Health, Inc.201910—
+6K181996MATRx PlusZephyr Sleep Technologies20182—
+6K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+6K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+6K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+6K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+7K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+7K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+7K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+7K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+7K232445CSF-4 (CSF-4)Cardiacsense20240—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+7K230823AusculThing ACCAusculthing OY20230—
+7K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+7K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+7K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—