510(k) Report

Devices descending from K915856

245 later devices reach Sensormedics 4000 Series Sleep System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+8K221179SomnoMetryNeumetry Medical, Inc.20223—
+8K220056iSyncWaveiMediSync, Inc.20220—
+8K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+8K210034EnsoSleepEnsodata, Inc.20210—
+8K203126S10 KirraResmed Pty, Ltd.20200—
+8K192753NeuralScan SystemMedeia, Inc.20203—
+8K191925MATRx PlusZephyr Sleep Technologies20191—
+8K171781eVox SystemEvoke Neuroscience, Inc.20176—
+8K160836Menai SystemResmed, Ltd.20166—
+8K152356SapphireRespironics, Inc.20164—
+8K151901AirViewResmed, Ltd.20151—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K254042WatchPAT SWItamar Medical, Ltd.20260—
+9K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+9K253767UB ERP SystemUniversal Brain20260—
+9K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+9K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K242485EveryWareBreas Medical AB20250—
+9K244027Sansa HsatHuxley Medical20252—
+9K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+9K241288Noxturnal WebNox Medical Ehf20242—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K221959Q21Neurofield, Inc.20230—
+9K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+9K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+9K200565GalapogosResmed Corp20213—
+9K200695MATRx plusZephyr Sleep Technologies20200—
+9K183226Care Orchestrator EssenceRespironics, Inc.20190—
+9K181053Care OrchestratorRespironics, Inc.20191—
+10K261747Report StudioBeacon Biosignals, Inc.20260—
+10K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+10K260585Noxturnal WebNox Medical Ehf20260—
+10K252497Sansa HsatHuxley Medical20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K241216myAirResmed Corp20242—
+10K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+11K250624myAirResmed Corp20251—
+12K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—