510(k) Report

Devices descending from K063036

24 later devices reach Opus HC482 Direct Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+1K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+1K1122713B Willow3B Products, LLC201211
+1K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+1K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+2K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+2K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+2K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+2K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+2K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+2K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+2K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+3K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+3K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+3K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+3K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+4K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+4K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+4K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+4K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+4K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+5K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+5K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+5K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—