510(k) Report

Devices descending from K984428

135 later devices reach Sullivan Autoset Nasal Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited20182—
+5K162905SleepWeaver 3D Nasal MaskCircadiance, LLC20170—
+5K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+5K153673AirFit N20Resmed, Ltd.20166—
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K130686Nasal Comfort FreedomLakeview Sleep Center20130—
+5K121642Wizard 230 Nasal Pilow MaskApex Medical Corp.20130—
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K121705GEOResmed, Ltd.20120—
+5K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+5K1034343B Flex-Lite3B Products, LLC20110—
+5K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+5K093124Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…Cardinal Health 207, Inc.20100—
+6K261262Altis Full Face MaskRespironics, Inc.20260—
+6K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+6K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K161978AirFit N20Resmed, Ltd.20165Class I
+6K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+6K140980TI Nasal MaskRespironics, Inc.20152Class I
+7K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—
+7K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+7K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+7K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+7K171212AirFit N20Resmed, Ltd.20173Class I
+8K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+8K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+8K180497Scone MaskResmed, Ltd.20181—
+9K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—