510(k) Report

Devices descending from K024191

110 later devices reach S7 Elite and Autoset Spirit Cpap Systems with Reslink through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241216myAirResmed Corp20242—
+8K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+8K181166Trilogy EvoRespironics, Inc.20195Class I
+9K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+9K250624myAirResmed Corp20251—
+9K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+9K240807VM-2000Ventis Medical, Inc.20240—
+9K193586Vivo 45 LSBreas Medical AB20212Class I
+10K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+10K233452Vivo 45 LSBreas Medical AB202501