510(k) Report

Devices descending from K071171

40 later devices reach Vpap Auto with H3I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082605Vpap Auto with Humidaire 3IResmed, Ltd.200933—
+1K080131Vpap STResmed, Ltd.200838—
+2K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101
+2K102513S9 Vpap ST with H5IResmed, Ltd.201111—
+2K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical20100—
+2K092186Vpap TXResmed, Ltd.200918—
+2K091947S8 Aspen with H4I PlusResmed, Ltd.200931—
+2K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical200911
+3K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+3K140159S9 Wanda Vpap STResmed, Ltd.20142—
+3K140124S9 EloueraResmed Corp20148—
+3K132606S9 Cronulla for HerResmed, Ltd.20140—
+3K123511S9 Vpap TXResmed, Ltd.20131—
+3K113714Vpap TXResmed, Ltd.20120—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K113288Vpap ST-aResmed, Ltd.20127—
+3K112914Vpap TXResmed, Ltd.20110—
+3K102586S9 Vpap Adapt with H5IResmed, Ltd.20116—
+4K203126S10 KirraResmed Pty, Ltd.20200—
+4K192177SysMed S/TSysmed (China) Co., Ltd.20200—
+4K160836Menai SystemResmed, Ltd.20166—
+4K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.20160—
+4K153061Juno VPAP ST-AResmed, Ltd.20163—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122324Vpap S-aResmed, Ltd.20120—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K113801Vpap AdaptResmed Corp20125—
+5K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+5K213169BPAP SystemBMC Medical Co., Ltd.20220—
+5K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+5K200565GalapogosResmed Corp20213—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K161492Juno VPAP ST-AResmed, Ltd.20171—
+5K140279S9 GreenhillsResmed, Ltd.20142—
+6K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+6K241216myAirResmed Corp20242—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+7K250624myAirResmed Corp20251—
+8K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—