510(k) Report

Devices descending from K013909

128 later devices reach S7 Elite CP AP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132371Easycare OnlineResmed, Ltd.20138—
+6K131982Remstar Auto a-Flex HTRespironics, Inc.20135Class I
+6K122769Remstar SERespironics, Inc.20123Class I
+6K113640Stellar 150Resmed Germany, Inc.20121—
+6K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+7K261360EasyCare Tx 2Resmed Corp20260—
+7K251889myAirResmed Corp20260—
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+7K242485EveryWareBreas Medical AB20250—
+7K241216myAirResmed Corp20242—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+7K183226Care Orchestrator EssenceRespironics, Inc.20190—
+7K181053Care OrchestratorRespironics, Inc.20191—
+7K122715Stellar 150Resmed Germany, Inc.20130Class I
+7K130077Remstar SERespironics, Inc.20132Class I
+7K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+8K251770SleepRes PAP SystemSleepres, Inc.20250—
+8K250624myAirResmed Corp20251—
+8K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+8K181166Trilogy EvoRespironics, Inc.20195Class I
+9K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+9K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+9K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+9K240807VM-2000Ventis Medical, Inc.20240—
+9K193586Vivo 45 LSBreas Medical AB20212Class I
+10K233452Vivo 45 LSBreas Medical AB202501