510(k) Report

Devices descending from K915856

245 later devices reach Sensormedics 4000 Series Sleep System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120447X4Advanced Brain Monitoring, Inc.201218—
+5K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+5K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+5K070263ApnealinkResmed Germany, Inc.200729—
+6K254058DistaSense (TM) (v1)Life Detection Technologies20260—
+6K260050WRAP SystemHuneo, LLC20260—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+6K252676The Circadia C300 System (C300)Circadia Health, Inc.20261—
+6K250851Hypnos (369054-200)Cadwell Industries, Inc.20250—
+6K251364Sleepiz One+ (2.5)Sleepiz AG20251—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K231733Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies, Ltd.20240—
+6K231546SomfitCompumedics Limited20231—
+6K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+6K221816Wesper LabWesper, Inc.20230—
+6K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K213463NightOwlEctosense NV20213—
+6K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+6K202142Sleepware G3Respironics, Inc.20202—
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+6K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+6K183559WatchPAT ONEItamar Medical, Ltd.20195—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K180608Lunoa SystemNightbalance BV20180—
+6K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+6K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+6K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+6K163665MATRx plusZephyr Sleep Technologies20173—
+6K152659V10Mediana Co., Ltd.20162—
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+6K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+6K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+6K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+6K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+6K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+6K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+6K140430740 SelectCas Medical Systems, Inc.20141—
+6K131379EarlysenseEarlysense, Ltd.20137—
+6K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+6K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+7K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+7K261286The Circadia C300 System (C300)Circadia Health, Inc.20260—
+7K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+7K253388Sleepiz One+ (Model 2.5)Sleepiz AG20260—
+7K252383Somfit DCompumedics Limited20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K242447Falcon HSTCompumedics Limited20250—
+7K233403Flexset SystemZeto, Inc.20241—
+7K233438SleepStageMLBeacon Biosignals, Inc.20240—
+7K214115MightySat -OTCMasimo Corporation20241—
+7K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+7K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+7K213911Microstream CO2 NanoPodCovidien, LLC20220—
+7K220095ANNE SleepSibel, Inc.20224—
+7K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K220028NightOwlEctosense NV20222—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K211632Pulse 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—
+7K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+7K200705Nurochek SystemCryptych Pty, Ltd.20200—
+7K192624ApneaTrakCadwell Industries, Inc.20200—
+7K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+7K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+7K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K182227Esprit NovaNeurozone Msh Incorporated20190—
+7K181996MATRx PlusZephyr Sleep Technologies20182—
+7K172735WR19 SystemZeto, Inc.20183—
+7K170138NeuronauteBioserenity20170—
+7K170497V10Mediana Co., Ltd.201711
+7K170182Cardiovit FT-1Schiller AG20170—
+7K162627EnsoSleepEnsodata, Inc.20179—
+7K150620740 SelectCas Medical Systems, Inc.201501
+7K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+7K140124S9 EloueraResmed Corp20148—
+7K132371Easycare OnlineResmed, Ltd.20138—
+7K131932Apnealink ProResmed Germany, Inc.20138—
+8K261360EasyCare Tx 2Resmed Corp20260—
+8K252628CassieWesper, Inc.20260—
+8K251889myAirResmed Corp20260—
+8K260455New Wave SystemZeto, Inc.20260—
+8K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+8K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+8K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+8K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+8K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K231355AuroraEnsodata20240—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+8K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—