Company ยท US
Resmed, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2026. Name variants (Inc, Corp, punctuation) are merged.
126510(k) clearances (6 in 12 months)
14recalls (1 in 12 months)
14recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 106 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 19 |
| CBK | Ventilator, Continuous, Facility Use | 8 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | 2 |
| LQZ | Device, Jaw Repositioning | 1 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 1 |
| MQC | Mouthguard, Prescription | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2026 | K261360 | EasyCare Tx 2 Resmed Corp | MOD |
| Jun 4, 2026 | K253553 | Orion Resmed Corp | BZD |
| May 27, 2026 | K254104 | ResScan Essentials Resmed Corp | BZD |
| Apr 8, 2026 | K251889 | myAir Resmed Corp | MNS |
| Feb 23, 2026 | K251661 | Mariana Minerva; Mariana Nimbus Resmed Pty , Ltd., AU | MNS |
| Dec 5, 2025 | K251657 | Personalized Therapy Comfort Settings (PTCS) Resmed Corp | BZD |
| May 28, 2025 | K250624 | myAir Resmed Corp | BZD |
| May 19, 2025 | K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System Resmed Pty , Ltd., AU | BZD |
| Sep 27, 2024 | K241939 | EasyCare Tx 2 Resmed Corp | BZD |
| Sep 26, 2024 | K241216 | myAir Resmed Corp | BZD |
| Jan 17, 2021 | K200565 | Galapogos Resmed Corp | BZD |
| Dec 18, 2020 | K203126 | S10 Kirra Resmed Pty , Ltd., AU | BZD |
| May 7, 2019 | K183512 | Moore Park Mask Resmed, Ltd., AU | BZD |
| Jun 15, 2018 | K180497 | Scone Mask Resmed, Ltd., AU | BZD |
| Apr 26, 2018 | K172875 | Astral 100/150 Resmed, Ltd., AU | CBK |
| Jan 3, 2018 | K170924 | AirFit F20 Resmed, Ltd., AU | BZD |
| Sep 28, 2017 | K171212 | AirFit N20 Resmed, Ltd., AU | BZD |
| Jan 19, 2017 | K161492 | Juno VPAP ST-A Resmed, Ltd., AU | MNS |
| Dec 15, 2016 | K160836 | Menai System Resmed, Ltd., AU | BZD |
| Nov 17, 2016 | K161978 | AirFit N20 Resmed, Ltd., AU | BZD |
| Sep 9, 2016 | K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx Resmed, Ltd., AU | MNS |
| Sep 9, 2016 | K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV Resmed, Ltd., AU | BZD |
| May 13, 2016 | K153563 | AirFit F20 Resmed, Ltd., AU | BZD |
| May 13, 2016 | K152068 | Astral 100/150 Resmed, Ltd., AU | CBK |
| May 2, 2016 | K153673 | AirFit N20 Resmed, Ltd., AU | BZD |
| Apr 13, 2016 | K153061 | Juno VPAP ST-A Resmed, Ltd., AU | MNS |
| Nov 5, 2015 | K151901 | AirView Resmed, Ltd., AU | CBK |
| Aug 13, 2015 | K143623 | Narval Brux Resmed Sas, FR | MQC |
| May 21, 2015 | K143603 | Darlinghurst Vented, Darlinghurst NV-AAV Resmed, Ltd., AU | BZD |
| Jul 31, 2014 | K140279 | S9 GREENHILLS Resmed, Ltd. | BZD |
| Jun 17, 2014 | K140159 | S9 WANDA VPAP ST Resmed, Ltd. | BZD |
| Jun 9, 2014 | K132901 | AIRSOFT F15 Resmed, Ltd. | BZD |
| Jun 4, 2014 | K133868 | ASTRAL VENTILATOR Resmed, Ltd. | CBK |
| May 16, 2014 | K140054 | RESCAN Resmed, Ltd. | BZD |
| May 12, 2014 | K140124 | S9 ELOUERA Resmed Corp | BZD |
| Jan 13, 2014 | K132606 | S9 CRONULLA FOR HER Resmed, Ltd. | BZD |
| Dec 20, 2013 | K132887 | AIRFIT N10 Resmed, Ltd. | BZD |
| Nov 22, 2013 | K132371 | EASYCARE ONLINE Resmed, Ltd. | MNS |
| Oct 21, 2013 | K132013 | SWIFT AIR Resmed, Ltd. | BZD |
| Mar 29, 2013 | K123789 | SWIFT FX NANO Resmed, Ltd. | BZD |
| Mar 21, 2013 | K123511 | S9 VPAP TX Resmed, Ltd. | MNS |
| Mar 14, 2013 | K123557 | EASYCARE ONLINE Resmed, Ltd. | MNS |
| Feb 27, 2013 | K123979 | QUATTRO AIR Resmed, Ltd. | BZD |
| Nov 13, 2012 | K122324 | VPAP S-A Resmed, Ltd. | MNS |
| Oct 23, 2012 | K121705 | GEO Resmed, Ltd. | BZD |
| May 25, 2012 | K113801 | VPAP ADAPT Resmed Corp | BZD |
| May 25, 2012 | K113714 | VPAP TX Resmed, Ltd. | MNS |
| Apr 20, 2012 | K113780 | EASYCARE TX SYSTEM (CONNEXUNS) Resmed, Ltd. | BZD |
| Mar 29, 2012 | K113288 | VPAP ST-A Resmed, Ltd. | MNS |
| Mar 27, 2012 | K113815 | RESSCAN Resmed, Ltd. | MNS |
Newest 50 of 126.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2026 | ResMed Ltd. Resmed Astral 100/150
Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventil Open, Classified |
CBK | K152068 K172875 |
| Dec 21, 2023 | ResMed Ltd. AirFit F30i Full Face Mask and User Guide Open, Classified |
BZD | K183512 |
| Dec 21, 2023 | ResMed Ltd. AirFit F30 Full Face Mask and User Guide Open, Classified |
BZD | K170924 |
| Dec 21, 2023 | ResMed Ltd. AirTouch N20 Nasal Mask and User Guide Open, Classified |
BZD | K161978 |
| Dec 21, 2023 | ResMed Ltd. AirFit N20 Nasal Mask and User Guide Open, Classified |
BZD | K171212 |
| Dec 21, 2023 | ResMed Ltd. AirTouch F20 Full Face Mask and User Guide Open, Classified |
BZD | K153563 |
| Dec 21, 2023 | ResMed Ltd. AirFit F20 Full Face Mask and User Guide Open, Classified |
BZD | K170924 |
| Dec 21, 2023 | ResMed Ltd. AirFit N10 Nasal Masks and User Guide Open, Classified |
BZD | K132887 |
| Oct 23, 2023 | ResMed Ltd. Astral 100 and Astral 150 ventilators Open, Classified |
CBK | K172875 |
| Dec 12, 2019 | ResMed Ltd. ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 Completed |
MNT | K122715 |
| Jul 12, 2016 | Resmed Corporation Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators Terminated |
BZD | K123979 |
| Feb 3, 2016 | Resmed Corporation Astral 100, 150
Model: 27001, 27003
In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients Terminated |
CBK | K133868 |
| Jun 10, 2015 | ResMed Ltd. Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. Terminated |
CBK | K133868 |
| Jul 3, 2007 | Resmed Corporation ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #3300 Terminated |
BZD | K033841 K041209 |