510(k) Report

Devices descending from K023135

28 later devices reach IMAGE3 SE Disposable Full Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083122Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd.20094—
+1K081670The Advantage Series Non-Vented (NV) Full Face MaskCardinal Health 207, Inc.20080—
+1K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+1K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc.20081—
+1K072588Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20077—
+1K062019Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDInnomed Technologies, Inc./Respcare, Inc.20068—
+1K060044Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd.20067—
+2K232836Family of DIMAR DMAX NIV masksDimar S.P.A.20240—
+2K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited20182—
+2K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…Fisher and Paykel Healthcare Limited20171—
+2K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+2K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd.20150—
+2K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+2K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+2K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+2K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation20076Class I
+3K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+3K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+3K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+3K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited20200—
+3K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+3K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+3K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+3K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+4K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—
+4K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+4K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+4K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—