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FDA 510(k)

myAir

K-Number: K251889 · 2026-04-08

ApplicantResmed Corp
Decision Date2026-04-08
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

myAir is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K251889. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the myAir?

myAir is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Resmed Corp. The 510(k) number is K251889.

When did myAir receive FDA 510(k) clearance?

myAir received FDA 510(k) clearance on 2026-04-08, under 510(k) number K251889.

Who is the listed applicant for myAir?

The FDA 510(k) record lists Resmed Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for myAir?

The FDA product code for myAir is MNS. This falls under the Neurology category.

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Other records listing Resmed Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253553OrionK254104ResScan EssentialsK251657Personalized Therapy Comfort Settings (PTCS)K250624myAirK241939EasyCare Tx 2K241216myAir

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Related Devices (Code: MNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.K251661Mariana Minerva; Mariana NimbusResmed Pty , Ltd.K240778Vivo 1, Vivo 2Breas Medical ABK231064ReddyPort ElbowSmd Manufacturing, LLCK213169BPAP SystemBMC Medical Co., Ltd.K171827ReddyPort NIV Access ElbowSmd Manufacturing, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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