510(k) Report

Devices descending from K083575

27 later devices reach Apnealink Plus, Model: 22328 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140124S9 EloueraResmed Corp20148—
+1K132371Easycare OnlineResmed, Ltd.20138—
+1K131932Apnealink ProResmed Germany, Inc.20138—
+2K261360EasyCare Tx 2Resmed Corp20260—
+2K251889myAirResmed Corp20260—
+2K203126S10 KirraResmed Pty, Ltd.20200—
+2K160836Menai SystemResmed, Ltd.20166—
+2K152356SapphireRespironics, Inc.20164—
+2K151901AirViewResmed, Ltd.20151—
+2K143272ApneaLink AirResmed Germany, Inc.20157—
+3K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+3K242485EveryWareBreas Medical AB20250—
+3K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+3K200565GalapogosResmed Corp20213—
+3K183226Care Orchestrator EssenceRespironics, Inc.20190—
+3K181053Care OrchestratorRespironics, Inc.20191—
+3K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+3K163665MATRx plusZephyr Sleep Technologies20173—
+4K242447Falcon HSTCompumedics Limited20250—
+4K241216myAirResmed Corp20242—
+4K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+4K192624ApneaTrakCadwell Industries, Inc.20200—
+4K181996MATRx PlusZephyr Sleep Technologies20182—
+5K250624myAirResmed Corp20251—
+5K191925MATRx PlusZephyr Sleep Technologies20191—
+6K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+6K200695MATRx plusZephyr Sleep Technologies20200—