FDA.report

510(k) K251889

Device
myAir
Applicant
Resmed Corp
510(k) number
K251889
Product code
MNS
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-08
Date received
2025-06-20
Regulation
868.5895
Classification name
Ventilator, Continuous, Non-Life-Supporting
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Rose Malonzo
Address
9001 Spectrum Center Blvd. San Diego CA US 92123 92123

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MNS

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K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.2026-03-17
K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.2026-02-23
K240778Vivo 1, Vivo 2Breas Medical AB2024-12-13
K231064ReddyPort ElbowSmd Manufacturing, LLC2023-07-13
K213169BPAP SystemBMC Medical Co., Ltd.2022-12-05
K171827ReddyPort NIV Access ElbowSmd Manufacturing, LLC2018-01-19
K161492Juno VPAP ST-AResmed, Ltd.2017-01-19
K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.2016-09-09
K153061Juno VPAP ST-AResmed, Ltd.2016-04-13
K132371EASYCARE ONLINEResmed, Ltd.2013-11-22
K123511S9 VPAP TXResmed, Ltd.2013-03-21
K123557EASYCARE ONLINEResmed, Ltd.2013-03-14
K122324VPAP S-AResmed, Ltd.2012-11-13
K113714VPAP TXResmed, Ltd.2012-05-25
K113288VPAP ST-AResmed, Ltd.2012-03-29