510(k) Report

Devices descending from K991648

58 later devices reach Reusable Contour II Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+1K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp.20113—
+1K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group201010—
+1K091843Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+1K091066Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20090—
+1K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group2007282
+1K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd.20074Class I
+1K050171IT Nasal MaskInnomed Technologies20050—
+1K013738Weinmann SomnomaskGottlieb Weinmann Geraete Fuer Medizin Und Arbeits20023—
+2K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+2K193206WiZARD 510 Nasal MaskApex Medical Corp.20200—
+2K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp.20191—
+2K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+2K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+2K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+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—
+2K110405Trublue Nasal MaskRespironics, Inc.20114—
+2K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+2K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+2K092043Bipap Synchrony 2Respironics, Inc.20094—
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+2K072755Galemed Cpap MaskGalemed Corp.20070—
+2K061653Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20062—
+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—
+3K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+3K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+3K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+3K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+3K103395Performax Total Face MaskRespironics, Inc.20110—
+3K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+3K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+3K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+3K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+3K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG20081—
+4K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+4K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+4K180619BongoInnomed Healthscience, Inc.20181—
+4K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+4K140980TI Nasal MaskRespironics, Inc.20152Class I
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20110—
+5K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+6K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+7K233452Vivo 45 LSBreas Medical AB202501