510(k) Report

Devices descending from K031656

52 later devices reach Bipap Harmony Ventilatory Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063540Bipap AutosvRespironics, Inc.200713—
+1K063533Bipap SynchronyRespironics, Inc.200730—
+1K053168Bipap FocusRespironics (Ireland) Limited2006111
+1K032834Bipap Pro 2 BI-Level SystemRespironics, Inc.200440—
+2K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group20090Class I
+2K092043Bipap Synchrony 2Respironics, Inc.20094—
+2K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group20090Class I
+2K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+2K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group2007282
+2K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc.200539—
+3K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K103395Performax Total Face MaskRespironics, Inc.20110—
+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—
+3K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+3K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+3K061034Bipap Plus M-Series BI-Level SystemRespironics, Inc.20060—
+3K050759Bipap AutoRespironics, Inc.2005371
+4K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+4K180619BongoInnomed Healthscience, Inc.20181—
+4K150639AF541 EE Full Face MaskRespironics, Inc.20150—
+4K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+4K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+4K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+5K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K212263Luna G3 BPAP System3B Medical, Inc.20220—
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+7K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+7K122769Remstar SERespironics, Inc.20123Class I
+8K233452Vivo 45 LSBreas Medical AB202501
+8K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+8K130077Remstar SERespironics, Inc.20132Class I
+9K251770SleepRes PAP SystemSleepres, Inc.20250—