510(k) Report

Devices descending from K061236

25 later devices reach Flexifit HC432 Full Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+1K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+1K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+2K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+2K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+2K1122713B Willow3B Products, LLC201211
+2K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+3K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+3K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+3K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+3K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+3K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+3K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+4K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+4K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+4K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+4K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+5K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+5K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+5K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+5K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+5K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+6K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+6K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+6K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—