Class Class II

myAir (K250624)

K250624 2025-05-28 Traditional
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Description

myAir by ResMed Corp, an FDA 510(k) cleared anesthesiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250624
Clearance Date2025-05-28
Clearance TypeTraditional
Product CodeBZD
Regulation Number868.5905

Categories

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Predicate lineage for K250624

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. myAir (K250624) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K241216myAirResmed Corp2024
K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.2020

Trace the full predicate network for K250624

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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