510(k) Report

Devices descending from K023244

113 later devices reach Mirage Full Face Mask Series 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+5K140980TI Nasal MaskRespironics, Inc.20152Class I
+6K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—
+6K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+6K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+6K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+6K171212AirFit N20Resmed, Ltd.20173Class I
+7K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+7K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+7K180497Scone MaskResmed, Ltd.20181—
+8K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—