510(k) Report

Devices descending from K040506

38 later devices reach Flexifil Series HC431 Full Face Mask, Model HC431A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+1K061653Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20062—
+1K061236Flexifit HC432 Full Face MaskFisher & Paykel Healthcare, Ltd.200625—
+1K060044Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd.20067—
+1K052249UtopiaRespcare, Inc.20050—
+2K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+2K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…Fisher and Paykel Healthcare Limited20171—
+2K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+2K083122Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd.20094—
+2K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200815—
+2K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG20081—
+2K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd.200624—
+3K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+3K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited20200—
+3K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited20182—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited20127—
+3K1122713B Willow3B Products, LLC201211
+3K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20110—
+3K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+3K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd.200914—
+4K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+4K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd.20176—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc.20130—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K121597Eson Nasal MaskFisher & Paykel Healthcare Limited20124—
+5K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—
+5K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd.20205—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+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—
+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—