510(k) Report

Devices descending from K090484

79 later devices reach Alice PDX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230148VlabDormotech Medical, Ltd.20230—
+1K183625SomnaPatchRespironics, Inc.20190—
+1K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+1K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+2K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+2K220111RespiraSensePmd Solutions20221—
+2K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+2K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+2K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+2K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+2K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+2K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+3K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+3K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+3K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+3K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+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—
+4K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+4K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+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—
+5K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+5K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K200705Nurochek SystemCryptych Pty, Ltd.20200—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+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—
+6K241397HinscopeHinlab Sas20240—
+6K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K221179SomnoMetryNeumetry Medical, Inc.20223—
+6K220056iSyncWaveiMediSync, Inc.20220—
+6K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+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—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K221959Q21Neurofield, Inc.20230—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+7K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+8K261747Report StudioBeacon Biosignals, Inc.20260—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K260585Noxturnal WebNox Medical Ehf20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—