510(k) Report

Devices descending from K013843

125 later devices reach Autoset Spirit Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K212263Luna G3 BPAP System3B Medical, Inc.20220—
+6K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+6K200565GalapogosResmed Corp20213—
+6K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc.20201—
+6K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+6K183226Care Orchestrator EssenceRespironics, Inc.20190—
+6K181053Care OrchestratorRespironics, Inc.20191—
+6K161492Juno VPAP ST-AResmed, Ltd.20171—
+6K140279S9 GreenhillsResmed, Ltd.20142—
+6K130077Remstar SERespironics, Inc.20132Class I
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+7K251770SleepRes PAP SystemSleepres, Inc.20250—
+7K241216myAirResmed Corp20242—
+7K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+7K181166Trilogy EvoRespironics, Inc.20195Class I
+8K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+8K250624myAirResmed Corp20251—
+8K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+8K240807VM-2000Ventis Medical, Inc.20240—
+8K193586Vivo 45 LSBreas Medical AB20212Class I
+9K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+9K233452Vivo 45 LSBreas Medical AB202501