510(k) Report

Devices descending from K021176

95 later devices reach Compumedics Somte System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073682Embletta GoldEmbla Systems, Inc.2008411
+1K072201Compumedics Somte PSG Recording SystemCompumedics Limited200848—
+1K052573Stardust IIRespironics, Inc.200502
+1K040194Compumedics Summit IPCompumedics USA, Ltd.200413—
+2K192469Nox Sleep SystemNox Medical20194—
+2K122516Embletta MPREmbla Systems2013271
+2K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+2K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited20101—
+2K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+2K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+2K043132Universal XacttraceMedcare Flaga200410—
+3K252330DeepRESPNox Medical Ehf20250—
+3K241960DeepRESPNox Medical Ehf20251—
+3K223539Dreem 3SBeacon Biosignals, Inc.20231—
+3K230073OktiCompumedics Limited20230—
+3K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+3K203343Wesper LabWesper, Inc.20211—
+3K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems20191—
+3K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+3K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+3K161579Watch-PAT200UItamar Medical, Ltd.201720—
+3K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+3K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+4K260050WRAP SystemHuneo, LLC20260—
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc.20240—
+4K242094Dreem 3SBeacon Biosignals, Inc.20240—
+4K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+4K221816Wesper LabWesper, Inc.20230—
+4K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K191031NightOwlEctosense NV20205—
+4K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+4K180775Watch-PAT300Itamar Medical, Ltd.201812—
+4K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+4K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+4K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+4K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+4K120447X4Advanced Brain Monitoring, Inc.201218—
+5K252628CassieWesper, Inc.20260—
+5K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+5K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K231355AuroraEnsodata20240—
+5K231546SomfitCompumedics Limited20231—
+5K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+5K213463NightOwlEctosense NV20213—
+5K183559WatchPAT ONEItamar Medical, Ltd.20195—
+5K180608Lunoa SystemNightbalance BV20180—
+5K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+5K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+5K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+5K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+6K252383Somfit DCompumedics Limited20250—
+6K233403Flexset SystemZeto, Inc.20241—
+6K233438SleepStageMLBeacon Biosignals, Inc.20240—
+6K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+6K220095ANNE SleepSibel, Inc.20224—
+6K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+6K220028NightOwlEctosense NV20222—
+6K200705Nurochek SystemCryptych Pty, Ltd.20200—
+6K182227Esprit NovaNeurozone Msh Incorporated20190—
+6K172735WR19 SystemZeto, Inc.20183—
+6K170138NeuronauteBioserenity20170—
+6K162627EnsoSleepEnsodata, Inc.20179—
+6K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+7K260455New Wave SystemZeto, Inc.20260—
+7K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+7K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+7K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+7K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+7K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+7K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+7K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+7K221179SomnoMetryNeumetry Medical, Inc.20223—
+7K220056iSyncWaveiMediSync, Inc.20220—
+7K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+7K210034EnsoSleepEnsodata, Inc.20210—
+7K192753NeuralScan SystemMedeia, Inc.20203—
+7K171781eVox SystemEvoke Neuroscience, Inc.20176—
+8K254042WatchPAT SWItamar Medical, Ltd.20260—
+8K253767UB ERP SystemUniversal Brain20260—
+8K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+8K244027Sansa HsatHuxley Medical20252—
+8K241288Noxturnal WebNox Medical Ehf20242—
+8K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+8K221959Q21Neurofield, Inc.20230—
+8K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+9K261747Report StudioBeacon Biosignals, Inc.20260—
+9K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+9K260585Noxturnal WebNox Medical Ehf20260—
+9K252497Sansa HsatHuxley Medical20250—