510(k) Report

Devices descending from K982454

42 later devices reach Bipap Vision Ventilatory Support through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd.20222—
+1K082660V60 Ventilator, Model V8000Respironics California, Inc.200914Class I
+1K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+1K072450Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc.20076—
+1K053168Bipap FocusRespironics (Ireland) Limited2006111
+1K031896Nasal-Air Critical CareInnomed Technologies20040—
+1K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc.20022Class I
+2K252182SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+2K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare20231—
+2K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+2K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc.20114Class I
+2K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group20095—
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+2K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc.200406
+2K034040Esprit Ventilator, Model V1000Respironics, Inc.20041Class I
+3K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+3K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+3K230173Servo-air Lite Ventilator SystemMaquet Critical Care AB20230—
+3K213521Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.20222—
+3K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+3K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+3K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc.20103—
+3K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+4K251888VPAP Pediatric Face MaskHsiner Co., Ltd.20260—
+4K242931HFT750UMekics Co., Ltd.20250—
+4K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc.20240—
+4K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K180619BongoInnomed Healthscience, Inc.20181—
+4K150638AF541 SE Full Face MaskRespironics, Inc.20151—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K233452Vivo 45 LSBreas Medical AB202501
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—