510(k) Report

Devices descending from K974879

93 later devices reach Model 7410 Voyager through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012554Remstar Auto Cpap SystemRespironics, Inc.200292—
+2K130828K Series Cpap SystemsCurative Medical, Inc.20140—
+2K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc.201210—
+2K021845Stardust II, Model 1011176Respironics, Inc.200429—
+2K041010Remstar Auto with C-Flex Cpap SystemRespironics, Inc.2004403
+2K032834Bipap Pro 2 BI-Level SystemRespironics, Inc.200440—
+2K031460Modification to Remstar Auto Cpap SystemRespironics, Inc.200374—
+2K021861Remstar Pro with C-Flex Cpap SystemRespironics, Inc.2002471
+3K1329673B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc.20134—
+3K132127Transcend AutoSomnetics International, Inc.20131—
+3K1317073B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems3B Medical, Inc.20134—
+3K091112Respironics Sleepeasy Cpap SystemRespironics, Inc.20094—
+3K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+3K052573Stardust IIRespironics, Inc.200502
+3K052110M-Series Pro Cpap SytemRespironics, Inc.20054215
+3K050759Bipap AutoRespironics, Inc.2005371
+3K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc.200539—
+3K042294Slumbergear (TM), Model Multiple (004, 005, 005, 007)Suiter Enterprises, Inc.20041—
+3K031064Invacare Polaris EX Cpap, Model ISP3000Invacare Corp.20040—
+4K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+4K141770Luna Cpap and Auto-Cpap System3B Medical, Inc.20153—
+4K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+4K140124S9 EloueraResmed Corp20148—
+4K132371Easycare OnlineResmed, Ltd.20138—
+4K131932Apnealink ProResmed Germany, Inc.20138—
+4K122769Remstar SERespironics, Inc.20123Class I
+4K100343Pap-CapPur-Sleep, Inc.20100—
+4K072996Remstar Pro M-Series Cpap & Heated Humidifier SystemRespironics, Inc.200741
+4K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+4K061034Bipap Plus M-Series BI-Level SystemRespironics, Inc.20060—
+5K261360EasyCare Tx 2Resmed Corp20260—
+5K251889myAirResmed Corp20260—
+5K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+5K203126S10 KirraResmed Pty, Ltd.20200—
+5K160836Menai SystemResmed, Ltd.20166—
+5K153387Luna CPAP and Auto CPAP System3B Medical, Inc.20162—
+5K152356SapphireRespironics, Inc.20164—
+5K151901AirViewResmed, Ltd.20151—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K130077Remstar SERespironics, Inc.20132Class I
+5K120285K Series Cpap System with Heated HumidiferCurative Medical, Inc.20123—
+5K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+5K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+5K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+6K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.20260—
+6K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+6K242485EveryWareBreas Medical AB20250—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K212263Luna G3 BPAP System3B Medical, Inc.20220—
+6K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+6K200565GalapogosResmed Corp20213—
+6K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+6K183226Care Orchestrator EssenceRespironics, Inc.20190—
+6K181053Care OrchestratorRespironics, Inc.20191—
+6K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+6K163665MATRx plusZephyr Sleep Technologies20173—
+6K123897K Series Cpap SystemsCurative Medical, Inc.20132—
+6K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+6K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+6K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+6K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+6K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+7K251770SleepRes PAP SystemSleepres, Inc.20250—
+7K242447Falcon HSTCompumedics Limited20250—
+7K241216myAirResmed Corp20242—
+7K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+7K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+7K192624ApneaTrakCadwell Industries, Inc.20200—
+7K181996MATRx PlusZephyr Sleep Technologies20182—
+7K180619BongoInnomed Healthscience, Inc.20181—
+7K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+7K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+7K131702K Series Cpap SystemsCurative Medical, Inc.20130—
+7K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+7K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+7K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+7K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+7K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+7K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+8K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+8K250624myAirResmed Corp20251—
+8K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+8K191925MATRx PlusZephyr Sleep Technologies20191—
+8K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+9K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+9K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+9K200695MATRx plusZephyr Sleep Technologies20200—
+9K181166Trilogy EvoRespironics, Inc.20195Class I
+10K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+10K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+10K240807VM-2000Ventis Medical, Inc.20240—
+10K193586Vivo 45 LSBreas Medical AB20212Class I
+11K233452Vivo 45 LSBreas Medical AB202501