510(k) Report

Devices descending from K010263

141 later devices reach Remstar Plus Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122769Remstar SERespironics, Inc.20123Class I
+1K102625Vega Cpap System/Heated Humidifier, Model CP-03Vega Technologies, Inc.20110—
+1K091112Respironics Sleepeasy Cpap SystemRespironics, Inc.20094—
+1K050990Remrest Heated HumidifierMedical Industries America, Inc.20050—
+1K042945Aura Cpap SystemAeiomed, Inc.20056—
+1K040202Salter Labs Cpap High Flow Cannula SystemSalter Labs20050—
+1K020777Bipap Synchrony Ventilatory Support System with BI-FlexRespironics, Inc.2002612
+1K012554Remstar Auto Cpap SystemRespironics, Inc.200292—
+2K130828K Series Cpap SystemsCurative Medical, Inc.20140—
+2K130077Remstar SERespironics, Inc.20132Class I
+2K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc.201210—
+2K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+2K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group20090Class I
+2K070328Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group200759—
+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
+3K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+3K150365Cloud9 SystemInsleep Technologies, LLC20150—
+3K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+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—
+3K121374ZI BlowerDeshum Medical20131—
+3K090113Breas Vivo 40 SystemBreas Medical AB200923—
+3K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+3K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group200926Class I
+3K082660V60 Ventilator, Model V8000Respironics California, Inc.200914Class I
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+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—
+4K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+4K251770SleepRes PAP SystemSleepres, Inc.20250—
+4K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+4K183226Care Orchestrator EssenceRespironics, Inc.20190—
+4K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+4K143035Flight 60 VentilatorFlight Medical Innovations, Ltd.20161—
+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—
+4K120726Flight 60 VentilatorFlight Medical Innovations, Ltd.20123—
+4K112754IVENT101Versamed Medical Systems, Ltd.20129—
+4K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+4K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc.20114Class I
+4K103167Stellar 150Resmed Germany, Inc.201120—
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K100343Pap-CapPur-Sleep, Inc.20100—
+4K093416Trilogy 200 VentilatorRespironics, Inc.201019Class I
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+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—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K242931HFT750UMekics Co., Ltd.20250—
+5K223120Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd.20240—
+5K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB20230—
+5K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.20222—
+5K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+5K203126S10 KirraResmed Pty, Ltd.20200—
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+5K160836Menai SystemResmed, Ltd.20166—
+5K153387Luna CPAP and Auto CPAP System3B Medical, Inc.20162—
+5K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+5K152356SapphireRespironics, Inc.20164—
+5K151901AirViewResmed, Ltd.20151—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K133868Astral VentilatorResmed, Ltd.2014102
+5K130171Flight 60 VentilatorFlight Medical Innovations, Ltd.20142—
+5K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+5K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+5K120285K Series Cpap System with Heated HumidiferCurative Medical, Inc.20123—
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K112914Vpap TXResmed, Ltd.20110—
+5K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+5K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+6K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.20260—
+6K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—