510(k) Report

Devices descending from K140124

8 later devices reach S9 Elouera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203126S10 KirraResmed Pty, Ltd.20200—
+1K160836Menai SystemResmed, Ltd.20166—
+2K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+2K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+2K200565GalapogosResmed Corp20213—
+3K241216myAirResmed Corp20242—
+4K250624myAirResmed Corp20251—
+5K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—