510(k) Report

Devices descending from K930656

184 later devices reach Sullivan Iii Nasal Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151901AirViewResmed, Ltd.20151—
+6K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+6K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.20150—
+6K133766Humicare D900Gruendler GmbH20140—
+6K140424Respironics Reusable Heated TubingRespironics, Inc.20142—
+6K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+6K132371Easycare OnlineResmed, Ltd.20138—
+6K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd.2013242
+6K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+6K122324Vpap S-aResmed, Ltd.20120—
+6K122769Remstar SERespironics, Inc.20123Class I
+6K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+6K113801Vpap AdaptResmed Corp20125—
+6K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+6K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+6K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+6K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+7K261360EasyCare Tx 2Resmed Corp20260—
+7K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+7K251889myAirResmed Corp20260—
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.20250—
+7K242485EveryWareBreas Medical AB20250—
+7K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical20240—
+7K233707HFT150Invent Medical Corporation20240—
+7K222292F&P myAirvo 3Fisher & Paykel Healthcare20240—
+7K223863BONHAWA Respiratory HumidifierTelesair, Inc.20230—
+7K221338F&P Airvo 3Fisher & Paykel Healthcare202321
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+7K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+7K203357HVT 2.0Vapotherm, Inc.20211—
+7K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+7K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.20210—
+7K200565GalapogosResmed Corp20213—
+7K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+7K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+7K183226Care Orchestrator EssenceRespironics, Inc.20190—
+7K181053Care OrchestratorRespironics, Inc.20191—
+7K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare201815—
+7K180474TNI softFlow 50Tni Medical AG20180—
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+7K140279S9 GreenhillsResmed, Ltd.20142—
+7K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+7K130077Remstar SERespironics, Inc.20132Class I
+7K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+8K254078HVT 2.0Vapotherm, Inc.20260—
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+8K251770SleepRes PAP SystemSleepres, Inc.20250—
+8K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…Fisher & Paykel Healthcare, Ltd.20250—
+8K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+8K241216myAirResmed Corp20242—
+8K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+8K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+8K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.20240—
+8K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+8K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+8K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd.20233—
+8K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+8K212263Luna G3 BPAP System3B Medical, Inc.20220—
+8K211096Optiflow Oxygen KitFisher & Paykel Healthcare, Ltd.20222—
+8K201723F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd.20212—
+8K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+8K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)Fisher & Paykel Healthcare, Ltd.20200—
+8K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+8K181166Trilogy EvoRespironics, Inc.20195Class I
+9K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited20260—
+9K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+9K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+9K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP20250—
+9K250624myAirResmed Corp20251—
+9K242931HFT750UMekics Co., Ltd.20250—
+9K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP20240—
+9K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+9K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP20240—
+9K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+9K240807VM-2000Ventis Medical, Inc.20240—
+9K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+9K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+9K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+9K193586Vivo 45 LSBreas Medical AB20212Class I
+10K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—
+10K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+10K233452Vivo 45 LSBreas Medical AB202501