510(k) Report

Devices descending from K112514

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

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