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ResMed Ltd.

FDA Regulatory Profile

Summary

Total Recalls
10 (9 Class I)
510(k) Clearances
119
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0542-2024Class IAirFit F30i Full Face Mask and User GuideNovember 20, 2023
Z-0541-2024Class IAirFit F30 Full Face Mask and User GuideNovember 20, 2023
Z-0537-2024Class IAirFit F20 Full Face Mask and User GuideNovember 20, 2023
Z-0538-2024Class IAirTouch F20 Full Face Mask and User GuideNovember 20, 2023
Z-0536-2024Class IAirFit N10 Nasal Masks and User GuideNovember 20, 2023
Z-0539-2024Class IAirFit N20 Nasal Mask and User GuideNovember 20, 2023
Z-0540-2024Class IAirTouch N20 Nasal Mask and User GuideNovember 20, 2023
Z-0111-2024Class IAstral 100 and Astral 150 ventilatorsSeptember 13, 2023
Z-0915-2020Class IResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150December 12, 2019
Z-1750-2015Class IIAstral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.May 5, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K251657Personalized Therapy Comfort Settings (PTCS)December 5, 2025
K250624myAirMay 28, 2025
K241939EasyCare Tx 2September 27, 2024
K241216myAirSeptember 26, 2024
K200565GalapogosJanuary 17, 2021
K183512Moore Park MaskMay 7, 2019
K180497Scone MaskJune 15, 2018
K172875Astral 100/150April 26, 2018
K170924AirFit F20January 3, 2018
K171212AirFit N20September 28, 2017
K161492Juno VPAP ST-AJanuary 19, 2017
K160836Menai SystemDecember 15, 2016
K161978AirFit N20November 17, 2016
K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVSeptember 9, 2016
K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxSeptember 9, 2016
K153563AirFit F20May 13, 2016
K152068Astral 100/150May 13, 2016
K153673AirFit N20May 2, 2016
K153061Juno VPAP ST-AApril 13, 2016
K151901AirViewNovember 5, 2015