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
+6K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+6K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.20150—
+6K132371Easycare OnlineResmed, Ltd.20138—
+6K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+6K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+6K122769Remstar SERespironics, Inc.20123Class I
+6K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+6K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+7K261262Altis Full Face MaskRespironics, Inc.20260—
+7K261360EasyCare Tx 2Resmed Corp20260—
+7K251889myAirResmed Corp20260—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+7K250624myAirResmed Corp20251—
+7K242485EveryWareBreas Medical AB20250—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+7K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—
+7K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+7K183226Care Orchestrator EssenceRespironics, Inc.20190—
+7K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+7K181053Care OrchestratorRespironics, Inc.20191—
+7K130077Remstar SERespironics, Inc.20132Class I
+8K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+8K251770SleepRes PAP SystemSleepres, Inc.20250—
+8K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+8K233452Vivo 45 LSBreas Medical AB202501
+8K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+8K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+8K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—