510(k) Report

Devices descending from K012554

92 later devices reach Remstar Auto Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130828K Series Cpap SystemsCurative Medical, Inc.20140—
+1K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc.201210—
+1K021845Stardust II, Model 1011176Respironics, Inc.200429—
+1K041010Remstar Auto with C-Flex Cpap SystemRespironics, Inc.2004403
+1K032834Bipap Pro 2 BI-Level SystemRespironics, Inc.200440—
+1K031460Modification to Remstar Auto Cpap SystemRespironics, Inc.200374—
+1K021861Remstar Pro with C-Flex Cpap SystemRespironics, Inc.2002471
+2K1329673B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc.20134—
+2K132127Transcend AutoSomnetics International, Inc.20131—
+2K1317073B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems3B Medical, Inc.20134—
+2K091112Respironics Sleepeasy Cpap SystemRespironics, Inc.20094—
+2K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+2K052573Stardust IIRespironics, Inc.200502
+2K052110M-Series Pro Cpap SytemRespironics, Inc.20054215
+2K050759Bipap AutoRespironics, Inc.2005371
+2K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc.200539—
+2K042294Slumbergear (TM), Model Multiple (004, 005, 005, 007)Suiter Enterprises, Inc.20041—
+2K031064Invacare Polaris EX Cpap, Model ISP3000Invacare Corp.20040—
+3K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+3K141770Luna Cpap and Auto-Cpap System3B Medical, Inc.20153—
+3K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+3K140124S9 EloueraResmed Corp20148—
+3K132371Easycare OnlineResmed, Ltd.20138—
+3K131932Apnealink ProResmed Germany, Inc.20138—
+3K122769Remstar SERespironics, Inc.20123Class I
+3K100343Pap-CapPur-Sleep, Inc.20100—
+3K072996Remstar Pro M-Series Cpap & Heated Humidifier SystemRespironics, Inc.200741
+3K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+3K061034Bipap Plus M-Series BI-Level SystemRespironics, Inc.20060—
+4K261360EasyCare Tx 2Resmed Corp20260—
+4K251889myAirResmed Corp20260—
+4K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K160836Menai SystemResmed, Ltd.20166—
+4K153387Luna CPAP and Auto CPAP System3B Medical, Inc.20162—
+4K152356SapphireRespironics, Inc.20164—
+4K151901AirViewResmed, Ltd.20151—
+4K143272ApneaLink AirResmed Germany, Inc.20157—
+4K130077Remstar SERespironics, Inc.20132Class I
+4K120285K Series Cpap System with Heated HumidiferCurative Medical, Inc.20123—
+4K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+4K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+4K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+5K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.20260—
+5K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+5K242485EveryWareBreas Medical AB20250—
+5K213169BPAP SystemBMC Medical Co., Ltd.20220—
+5K212263Luna G3 BPAP System3B Medical, Inc.20220—
+5K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+5K200565GalapogosResmed Corp20213—
+5K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+5K183226Care Orchestrator EssenceRespironics, Inc.20190—
+5K181053Care OrchestratorRespironics, Inc.20191—
+5K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+5K163665MATRx plusZephyr Sleep Technologies20173—
+5K123897K Series Cpap SystemsCurative Medical, Inc.20132—
+5K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+5K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+5K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+5K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+5K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+6K251770SleepRes PAP SystemSleepres, Inc.20250—
+6K242447Falcon HSTCompumedics Limited20250—
+6K241216myAirResmed Corp20242—
+6K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+6K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+6K192624ApneaTrakCadwell Industries, Inc.20200—
+6K181996MATRx PlusZephyr Sleep Technologies20182—
+6K180619BongoInnomed Healthscience, Inc.20181—
+6K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+6K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+6K131702K Series Cpap SystemsCurative Medical, Inc.20130—
+6K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+6K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+6K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+6K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+6K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+6K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K250624myAirResmed Corp20251—
+7K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+7K191925MATRx PlusZephyr Sleep Technologies20191—
+7K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+8K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+8K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+8K200695MATRx plusZephyr Sleep Technologies20200—
+8K181166Trilogy EvoRespironics, Inc.20195Class I
+9K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+9K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+9K240807VM-2000Ventis Medical, Inc.20240—
+9K193586Vivo 45 LSBreas Medical AB20212Class I
+10K233452Vivo 45 LSBreas Medical AB202501