510(k) Report

Devices descending from K071509

28 later devices reach Bipap Synchrony 2 Ventilatory Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+1K092043Bipap Synchrony 2Respironics, Inc.20094—
+1K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+2K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+2K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+2K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+2K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+2K103395Performax Total Face MaskRespironics, Inc.20110—
+2K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+2K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+2K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+2K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+3K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+3K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+3K180619BongoInnomed Healthscience, Inc.20181—
+3K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+3K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+3K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+3K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+3K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+6K233452Vivo 45 LSBreas Medical AB202501