510(k) Report

Devices descending from K080209

15 later devices reach Fisher and Paykel Healthcare Zest Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+2K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+2K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+2K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+3K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+3K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+3K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+4K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+4K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+5K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+5K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+5K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+5K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+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—