510(k) Report

Devices descending from K002465

75 later devices reach Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp.20113—
+1K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+1K071915Cpap MaskArcimed Laboratories, LLC20080—
+1K073600Comfortgel Full Face MaskRespironics Inc., Sleep & Home Respiratory Group200820—
+1K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc.20081—
+1K070321Twilight Full Face MaskInvacare Corp.20070—
+1K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd.20074Class I
+1K052249UtopiaRespcare, Inc.20050—
+1K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc.200521—
+1K023135IMAGE3 SE Disposable Full Face MaskRespironics, Inc.200328—
+2K193206WiZARD 510 Nasal MaskApex Medical Corp.20200—
+2K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp.20191—
+2K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+2K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd.20150—
+2K140580Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics)20150—
+2K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+2K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+2K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group201010—
+2K090935Minime Pediatric MaskSleepnet Corporation20095—
+2K083122Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd.20094—
+2K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group20092Class I
+2K081670The Advantage Series Non-Vented (NV) Full Face MaskCardinal Health 207, Inc.20080—
+2K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+2K072588Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20077—
+2K072755Galemed Cpap MaskGalemed Corp.20070—
+2K062019Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDInnomed Technologies, Inc./Respcare, Inc.20068—
+2K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation200620—
+2K060044Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd.20067—
+3K243023WiZARD 520 Full Face MaskWellell, Inc.20250—
+3K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+3K232836Family of DIMAR DMAX NIV masksDimar S.P.A.20240—
+3K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited20182—
+3K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…Fisher and Paykel Healthcare Limited20171—
+3K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+3K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+3K142554Revolution Full Face MaskRespironics, Inc.20150Class I
+3K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+3K132887Airfit N10Resmed, Ltd.20137Class I
+3K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+3K121692Minime 2 Nasal MaskSleepnet Corporation20120—
+3K120463Mojo, VerasealSleepnet Corporation20124Class I
+3K110405Trublue Nasal MaskRespironics, Inc.20114—
+3K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+3K102224Pixi Pediatric MaskResmed, Ltd.20103—
+3K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+3K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+3K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation20076Class I
+4K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+4K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+4K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented…Sleepnet Corporation20241—
+4K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+4K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited20200—
+4K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+4K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation20191Class I
+4K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+4K153673AirFit N20Resmed, Ltd.20166—
+4K151683SleepWeaver Advance Pediatric Nasal CPAP MaskCircadiance, LLC20160—
+4K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+4K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+4K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+4K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+5K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…Dcstar, Inc.20260—
+5K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—
+5K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskSleepnet Corporation20240—
+5K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+5K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+5K161978AirFit N20Resmed, Ltd.20165Class I
+5K140980TI Nasal MaskRespironics, Inc.20152Class I
+6K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+6K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03…Suzhou Yuyue Medical Technology Co., Ltd.20210—
+6K171212AirFit N20Resmed, Ltd.20173Class I
+7K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+7K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet Corporation20260—
+7K180497Scone MaskResmed, Ltd.20181—
+8K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—