510(k) Report

Devices descending from K883825

89 later devices reach Modified Sanders BI-Papeasy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972605Ems Nasal Cpap MaskEngineered Medical Systems19980—
+1K963761Quartet Clinical SystemRespironics, Inc.19970—
+1K964363Bipap Duet SystemRespironics, Inc.19970—
+1K955324Bipap S/T-D 30 SystemRespironics, Inc.199644—
+1K951264Bipap Model S/T-DRespironics, Inc.199685—
+2K991648Reusable Contour II Nasal MaskRespironics, Inc.199958—
+2K990574Stick-on Disposable Nasal Mask, Model 312174, 1001964Respironics, Inc.19990—
+2K982454Bipap Vision Ventilatory SupportRespironics, Inc.1998422
+2K973004Knightstar 335Puritan Bennett Corp.19980—
+3K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+3K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+3K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp.20113—
+3K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group201010—
+3K091843Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+3K091066Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group20090—
+3K082660V60 Ventilator, Model V8000Respironics California, Inc.200914Class I
+3K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+3K072450Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc.20076—
+3K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group2007282
+3K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd.20074Class I
+3K053168Bipap FocusRespironics (Ireland) Limited2006111
+3K050171IT Nasal MaskInnomed Technologies20050—
+3K031896Nasal-Air Critical CareInnomed Technologies20040—
+3K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc.20022Class I
+3K013738Weinmann SomnomaskGottlieb Weinmann Geraete Fuer Medizin Und Arbeits20023—
+4K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+4K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+4K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+4K193206WiZARD 510 Nasal MaskApex Medical Corp.20200—
+4K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp.20191—
+4K150685Skynector CPAP MaskSky Wise Medical Instrument (Shen Zhen) Co., Ltd.20150—
+4K133009Nasal Mask, Nasal Mask, Full Face MaskBMC Medical Co., Ltd.20141—
+4K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—
+4K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company20121—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+4K110405Trublue Nasal MaskRespironics, Inc.20114—
+4K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc.20114Class I
+4K103786Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd.20110—
+4K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+4K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+4K092043Bipap Synchrony 2Respironics, Inc.20094—
+4K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+4K072755Galemed Cpap MaskGalemed Corp.20070—
+4K061653Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20062—
+4K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+4K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K243023WiZARD 520 Full Face MaskWellell, Inc.20250—
+5K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc.20240—
+5K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+5K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB20230—
+5K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.20222—
+5K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)Bmc Medical., Ltd.20170—
+5K122847Kangaroo Nasal MaskRespironics, Inc.20133—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+5K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+5K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+5K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+5K103395Performax Total Face MaskRespironics, Inc.20110—
+5K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+5K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+5K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+5K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+5K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+5K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG20081—
+6K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+6K242931HFT750UMekics Co., Ltd.20250—
+6K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+6K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K180619BongoInnomed Healthscience, Inc.20181—
+6K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+6K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+6K140980TI Nasal MaskRespironics, Inc.20152Class I
+6K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+6K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+6K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+6K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20110—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+8K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—
+8K233452Vivo 45 LSBreas Medical AB202501
+8K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—