510(k) Report

Devices descending from K042916

71 later devices reach Watch Pat 100S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081037Watch-Pat 200I (WP200I)Itamar Medical200825—
+1K080427Watch-Pat Model 100S-2Itamar Medical200825—
+1K071230Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc.200743—
+2K111314Morpheus OXWidemed, Ltd.20110—
+2K110705Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201141—
+2K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical200824—
+3K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+3K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123—
+4K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+4K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.201422—
+4K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+5K161579Watch-PAT200UItamar Medical, Ltd.201720—
+5K153070Watch-PAT200UItamar Medical, Ltd.20160—
+5K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+5K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+5K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—
+5K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+5K120447X4Advanced Brain Monitoring, Inc.201218—
+6K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+6K191031NightOwlEctosense NV20205—
+6K180775Watch-PAT300Itamar Medical, Ltd.201812—
+6K180608Lunoa SystemNightbalance BV20180—
+6K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+6K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System -…Advanced Brain Monitoring, Inc.20151—
+6K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+6K131383X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic SoftwareAdvanced Brain Monitoring, Inc.201314—
+7K260050WRAP SystemHuneo, LLC20260—
+7K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+7K233403Flexset SystemZeto, Inc.20241—
+7K233438SleepStageMLBeacon Biosignals, Inc.20240—
+7K231546SomfitCompumedics Limited20231—
+7K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+7K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+7K213463NightOwlEctosense NV20213—
+7K200705Nurochek SystemCryptych Pty, Ltd.20200—
+7K183559WatchPAT ONEItamar Medical, Ltd.20195—
+7K182227Esprit NovaNeurozone Msh Incorporated20190—
+7K172735WR19 SystemZeto, Inc.20183—
+7K170138NeuronauteBioserenity20170—
+7K162627EnsoSleepEnsodata, Inc.20179—
+7K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+8K260455New Wave SystemZeto, Inc.20260—
+8K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+8K252383Somfit DCompumedics Limited20250—
+8K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+8K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+8K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+8K221179SomnoMetryNeumetry Medical, Inc.20223—
+8K220056iSyncWaveiMediSync, Inc.20220—
+8K220095ANNE SleepSibel, Inc.20224—
+8K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+8K220028NightOwlEctosense NV20222—
+8K210034EnsoSleepEnsodata, Inc.20210—
+8K192753NeuralScan SystemMedeia, Inc.20203—
+8K171781eVox SystemEvoke Neuroscience, Inc.20176—
+9K253767UB ERP SystemUniversal Brain20260—
+9K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+9K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+9K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+9K241288Noxturnal WebNox Medical Ehf20242—
+9K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+9K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+9K221959Q21Neurofield, Inc.20230—
+9K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+9K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+10K261747Report StudioBeacon Biosignals, Inc.20260—
+10K254042WatchPAT SWItamar Medical, Ltd.20260—
+10K260585Noxturnal WebNox Medical Ehf20260—
+10K244027Sansa HsatHuxley Medical20252—
+11K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+11K252497Sansa HsatHuxley Medical20250—