510(k) Report

Devices descending from K110705

41 later devices reach Apnea Risk Evaluation System (Ares) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+2K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+2K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+3K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+3K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+3K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+3K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+3K120447X4Advanced Brain Monitoring, Inc.201218—
+4K180608Lunoa SystemNightbalance BV20180—
+4K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+4K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+4K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+4K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+5K260050WRAP SystemHuneo, LLC20260—
+5K233403Flexset SystemZeto, Inc.20241—
+5K233438SleepStageMLBeacon Biosignals, Inc.20240—
+5K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+5K200705Nurochek SystemCryptych Pty, Ltd.20200—
+5K182227Esprit NovaNeurozone Msh Incorporated20190—
+5K172735WR19 SystemZeto, Inc.20183—
+5K170138NeuronauteBioserenity20170—
+5K162627EnsoSleepEnsodata, Inc.20179—
+5K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+6K260455New Wave SystemZeto, Inc.20260—
+6K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+6K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+6K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+6K221179SomnoMetryNeumetry Medical, Inc.20223—
+6K220056iSyncWaveiMediSync, Inc.20220—
+6K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+6K210034EnsoSleepEnsodata, Inc.20210—
+6K192753NeuralScan SystemMedeia, Inc.20203—
+6K171781eVox SystemEvoke Neuroscience, Inc.20176—
+7K253767UB ERP SystemUniversal Brain20260—
+7K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+7K241288Noxturnal WebNox Medical Ehf20242—
+7K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+7K221959Q21Neurofield, Inc.20230—
+7K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+8K261747Report StudioBeacon Biosignals, Inc.20260—
+8K260585Noxturnal WebNox Medical Ehf20260—