510(k) Report

Devices descending from K041156

89 later devices reach Avant Digital Pulse Oximetry System, Models 4000, 4001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052669Avant Digital Pulse Oximetry System, Model 4000, 4100Nonin Medical, Inc.200511—
+1K0433594100 Patient Oximeter ModuleNonin Medical, Inc.200575—
+1K043162PMP4 Oxy ProCard Guard Scientific Survival, Ltd.20040—
+2K191574OxSAT 100S.L.P., Ltd.20200—
+2K162580Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20172—
+2K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+2K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+2K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+2K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+3K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+3K242290DormoTech NLabDormotech Medical, Ltd.20250—
+3K200537OxxiomTrue Wearables, Inc.20200—
+3K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+3K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+3K143272ApneaLink AirResmed Germany, Inc.20157—
+3K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+3K131021Pulse OximeterNonin Medical, Inc.20133—
+3K124062QDC-Pro, and Nox-RipNox Medical20133—
+3K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+3K121617SensicardiacDiacoustic Medical (Pty)201210—
+3K113865PultolSharp Corporation20120—
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+4K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+4K191403Pulse OximeterNonin Medical, Inc.20191—
+4K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+4K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+4K163665MATRx plusZephyr Sleep Technologies20173—
+4K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+4K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+4K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+4K140785Pulse OximeterNonin Medical, Inc.20140—
+4K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+4K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+4K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+4K131287CardiosleeveRijuven Corp20131—
+4K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+5K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+5K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+5K242447Falcon HSTCompumedics Limited20250—
+5K233827OxiWearOxiwear, Inc.20240—
+5K214115MightySat -OTCMasimo Corporation20241—
+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—
+5K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+5K201299HD StethHd Medical, Inc.20200—
+5K192624ApneaTrakCadwell Industries, Inc.20200—
+5K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+5K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+5K181988eMurmur IDCsd Labs GmbH20197—
+5K181352Loop SystemSpry Health, Inc.201910—
+5K181996MATRx PlusZephyr Sleep Technologies20182—
+5K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+5K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+5K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+6K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+6K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+6K232445CSF-4 (CSF-4)Cardiacsense20240—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+6K230823AusculThing ACCAusculthing OY20230—
+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—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K220351Polso WatchChronisense Medical, Ltd.20220—
+6K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+6K220766eMurmur Heart AICsd Labs GmbH20221—
+6K191925MATRx PlusZephyr Sleep Technologies20191—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K252284eMurmur Heart AICsd Labs20250—
+7K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+7K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K240901StethophoneSparrow Acoustics, Inc.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K200695MATRx plusZephyr Sleep Technologies20200—
+8K252595Stethophone ProSparrow Acoustics, Inc.20250—
+8K250515EpiMonitorEmpatica S.r.l.20250—