Class Class II
myAir (K241216)
Description
myAir by ResMed Corp, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241216
Clearance Date2024-09-26
Clearance TypeTraditional
Product CodeBZD
Regulation Number868.5905
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241216
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 (K241216) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220028 | NightOwl | Ectosense NV | 2022 |
| K200565 | Galapogos | Resmed Corp | 2021 |
| K200656 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250624 | myAir | Resmed Corp | 2025 |
Trace the full predicate network for K241216
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.