510(k) Report

Devices descending from K961783

233 later devices reach Sullivan Vpap II ST Nasal Vpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160836Menai SystemResmed, Ltd.20166—
+4K161978AirFit N20Resmed, Ltd.20165Class I
+4K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+4K153563AirFit F20Resmed, Ltd.20166Class I
+4K153061Juno VPAP ST-AResmed, Ltd.20163—
+4K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K132901Airsoft F15Resmed, Ltd.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K121747Facefit and Facefit Ported Non-Invasive Ventilation MasksIntersurgical Incorporated20130—
+4K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+4K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.20122—
+4K122324Vpap S-aResmed, Ltd.20120—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K120463Mojo, VerasealSleepnet Corporation20124Class I
+4K113801Vpap AdaptResmed Corp20125—
+4K120757Sleepweaver Elan Nasal Cpap MaskCircadiance, LLC20121—
+4K113640Stellar 150Resmed Germany, Inc.20121—
+4K113815ResscanResmed, Ltd.201215—
+4K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K113127Mirage QuattroResmed, Ltd.20124—
+4K110444Mirage MicroResmed, Ltd.20110—
+4K102224Pixi Pediatric MaskResmed, Ltd.20103—
+4K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group20090Class I
+4K092043Bipap Synchrony 2Respironics, Inc.20094—
+4K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+4K090113Breas Vivo 40 SystemBreas Medical AB200923—
+4K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+4K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+4K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group20090Class I
+4K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+4K082983Resscan-ProResmed, Ltd.200913—
+4K081321Modification to Mirage MicroResmed, Ltd.20082—
+4K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+4K071915Cpap MaskArcimed Laboratories, LLC20080—
+4K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+4K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group2007282
+5K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+5K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+5K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20241—
+5K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+5K230476Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967)20230—
+5K213169BPAP SystemBMC Medical Co., Ltd.20220—
+5K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+5K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+5K200565GalapogosResmed Corp20213—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+5K170924AirFit F20Resmed, Ltd.20183Class I
+5K171212AirFit N20Resmed, Ltd.20173Class I
+5K162905SleepWeaver 3D Nasal MaskCircadiance, LLC20170—
+5K161492Juno VPAP ST-AResmed, Ltd.20171—
+5K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+5K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+5K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+5K140980TI Nasal MaskRespironics, Inc.20152Class I
+5K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.20141—
+5K140279S9 GreenhillsResmed, Ltd.20142—
+5K140054RescanResmed, Ltd.201410—
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K123557Easycare OnlineResmed, Ltd.20139—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+5K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+5K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+5K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+5K103395Performax Total Face MaskRespironics, Inc.20110—
+5K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+5K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+5K093684Easycare OnlineResmed, Ltd.201012—
+5K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+5K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+6K253553OrionResmed Corp20260—
+6K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.20260—
+6K254104ResScan EssentialsResmed Corp20260—
+6K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+6K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+6K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+6K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemResmed Pty, Ltd.20251—
+6K242931HFT750UMekics Co., Ltd.20250—
+6K242935Respiration Data Management Software (PAP Link PC)BMC Medical Co., Ltd.20250—
+6K241216myAirResmed Corp20242—
+6K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K212263Luna G3 BPAP System3B Medical, Inc.20220—
+6K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+6K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+6K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K180619BongoInnomed Healthscience, Inc.20181—
+6K180497Scone MaskResmed, Ltd.20181—
+6K160127iCodeConnect3B Medical, Inc.20160—
+6K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+6K152810DeVilbiss DV6WM Wireless ModemDevilbiss Healthcare, LLC20160—
+6K152356SapphireRespironics, Inc.20164—
+6K151901AirViewResmed, Ltd.20151—
+6K150639AF541 EE Full Face MaskRespironics, Inc.20150—