510(k) Report

Devices descending from K091947

31 later devices reach S8 Aspen with H4I Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140124S9 EloueraResmed Corp20148—
+1K132606S9 Cronulla for HerResmed, Ltd.20140—
+1K123511S9 Vpap TXResmed, Ltd.20131—
+1K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+1K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+1K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+2K203126S10 KirraResmed Pty, Ltd.20200—
+2K160836Menai SystemResmed, Ltd.20166—
+2K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+2K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+2K140159S9 Wanda Vpap STResmed, Ltd.20142—
+2K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+2K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+2K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+2K113801Vpap AdaptResmed Corp20125—
+2K113288Vpap ST-aResmed, Ltd.20127—
+3K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+3K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+3K200565GalapogosResmed Corp20213—
+3K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+3K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+3K153061Juno VPAP ST-AResmed, Ltd.20163—
+3K140279S9 GreenhillsResmed, Ltd.20142—
+3K122324Vpap S-aResmed, Ltd.20120—
+4K241216myAirResmed Corp20242—
+4K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+4K213169BPAP SystemBMC Medical Co., Ltd.20220—
+4K161492Juno VPAP ST-AResmed, Ltd.20171—
+5K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+5K250624myAirResmed Corp20251—
+6K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—