510(k) Report

Devices descending from K043607

39 later devices reach Bipap Pro 2 BI-Level System with BI-Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061034Bipap Plus M-Series BI-Level SystemRespironics, Inc.20060—
+1K050759Bipap AutoRespironics, Inc.2005371
+2K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc.20143—
+2K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group200735—
+3K201620Luna® G3 BPAP 25A3B Medical, Inc.20212—
+3K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group200922Class I
+3K090243Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group20090—
+3K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+4K213169BPAP SystemBMC Medical Co., Ltd.20220—
+4K212263Luna G3 BPAP System3B Medical, Inc.20220—
+4K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+4K113068Remstar Auto a-Flex HTRespironics, Inc.20119Class I
+4K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+4K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc.201011Class I
+4K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+5K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+5K180619BongoInnomed Healthscience, Inc.20181—
+5K143677DeVilbiss Intellipap2/DeVilbiss BLUEDevilbiss Healthcare, LLC20150—
+5K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+5K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+5K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+5K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K122769Remstar SERespironics, Inc.20123Class I
+5K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+5K111378Oximetry Interface KitPhilips Respironics, Inc.20110Class I
+5K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc.20111Class I
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K130077Remstar SERespironics, Inc.20132Class I
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+7K251770SleepRes PAP SystemSleepres, Inc.20250—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K181166Trilogy EvoRespironics, Inc.20195Class I
+8K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+8K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+8K240807VM-2000Ventis Medical, Inc.20240—
+8K193586Vivo 45 LSBreas Medical AB20212Class I
+9K233452Vivo 45 LSBreas Medical AB202501