510(k) Report

Devices descending from K973920

100 later devices reach Stardust through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052573Stardust IIRespironics, Inc.200502
+1K021845Stardust II, Model 1011176Respironics, Inc.200429—
+1K000253Silent Night VSleep Solutions, Inc.200069—
+2K110486AccusomNovasom, Inc.20111—
+2K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+2K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+2K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc.2005631
+3K220012BresoDX1Bresotec, Inc.20220—
+3K140124S9 EloueraResmed Corp20148—
+3K132371Easycare OnlineResmed, Ltd.20138—
+3K131932Apnealink ProResmed Germany, Inc.20138—
+3K111314Morpheus OXWidemed, Ltd.20110—
+3K110001Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd.201161
+3K083325N-600X with SPD, Oximax N-600XCovidien200953—
+3K081861Holter LX AnalysisNorth East Monitoring, Inc.20080—
+3K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+3K070855Sleep QualityDynadx Corporation20080—
+4K261360EasyCare Tx 2Resmed Corp20260—
+4K251889myAirResmed Corp20260—
+4K201921Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd.20210—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K160836Menai SystemResmed, Ltd.20166—
+4K152356SapphireRespironics, Inc.20164—
+4K151901AirViewResmed, Ltd.20151—
+4K143272ApneaLink AirResmed Germany, Inc.20157—
+4K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+4K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+4K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+4K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+4K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc.20114—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+5K242485EveryWareBreas Medical AB20250—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+5K200565GalapogosResmed Corp20213—
+5K183226Care Orchestrator EssenceRespironics, Inc.20190—
+5K181053Care OrchestratorRespironics, Inc.20191—
+5K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+5K163665MATRx plusZephyr Sleep Technologies20173—
+5K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+5K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+5K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+5K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+5K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+6K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+6K242447Falcon HSTCompumedics Limited20250—
+6K241216myAirResmed Corp20242—
+6K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+6K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+6K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+6K192624ApneaTrakCadwell Industries, Inc.20200—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K181996MATRx PlusZephyr Sleep Technologies20182—
+6K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+6K152659V10Mediana Co., Ltd.20162—
+6K152043Diagnostic Station DS20Schiller AG20161—
+6K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+6K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+6K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+6K140430740 SelectCas Medical Systems, Inc.20141—
+7K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K250624myAirResmed Corp20251—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K214115MightySat -OTCMasimo Corporation20241—
+7K213911Microstream CO2 NanoPodCovidien, LLC20220—
+7K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+7K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+7K191925MATRx PlusZephyr Sleep Technologies20191—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K170497V10Mediana Co., Ltd.201711
+7K170182Cardiovit FT-1Schiller AG20170—
+7K150620740 SelectCas Medical Systems, Inc.201501
+8K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+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—
+8K200695MATRx plusZephyr Sleep Technologies20200—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K260157LifeLens Physiological MonitorLifeLens Technologies, 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—
+9K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+10K250515EpiMonitorEmpatica S.r.l.20250—