510(k) Report

Devices descending from K061405

30 later devices reach Apnealink, Model 22302 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070263ApnealinkResmed Germany, Inc.200729—
+2K111314Morpheus OXWidemed, Ltd.20110—
+2K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+3K140124S9 EloueraResmed Corp20148—
+3K132371Easycare OnlineResmed, Ltd.20138—
+3K131932Apnealink ProResmed Germany, Inc.20138—
+4K261360EasyCare Tx 2Resmed Corp20260—
+4K251889myAirResmed Corp20260—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K160836Menai SystemResmed, Ltd.20166—
+4K152356SapphireRespironics, Inc.20164—
+4K151901AirViewResmed, Ltd.20151—
+4K143272ApneaLink AirResmed Germany, Inc.20157—
+5K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+5K242485EveryWareBreas Medical AB20250—
+5K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+5K200565GalapogosResmed Corp20213—
+5K183226Care Orchestrator EssenceRespironics, Inc.20190—
+5K181053Care OrchestratorRespironics, Inc.20191—
+5K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+5K163665MATRx plusZephyr Sleep Technologies20173—
+6K242447Falcon HSTCompumedics Limited20250—
+6K241216myAirResmed Corp20242—
+6K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+6K192624ApneaTrakCadwell Industries, Inc.20200—
+6K181996MATRx PlusZephyr Sleep Technologies20182—
+7K250624myAirResmed Corp20251—
+7K191925MATRx PlusZephyr Sleep Technologies20191—
+8K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—
+8K200695MATRx plusZephyr Sleep Technologies20200—