Resmed, Ltd.
Medical device manufacturer in San Diego, CA.
126510(k) clearances
0PMA approvals
14recalls
Device types
- BZD Ventilator, Non-Continuous (Respirator) 97
- MNS Ventilator, Continuous, Non-Life-Supporting 19
- CBK Ventilator, Continuous, Facility Use 4
- BTT Humidifier, Respiratory Gas, (Direct… 2
- MNT Sv70 Ventilator 1
- LQZ Device, Jaw Repositioning 1
- MQC Mouthguard, Prescription 1
- MOD Accessory To Continuous Ventilator… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261360 | EasyCare Tx 2MOD · Traditional | 08/27/2026SE |
| K253553 | OrionBZD · Traditional | 06/04/2026SE |
| K254104 | ResScan EssentialsBZD · Traditional | 05/27/2026SE |
| K251889 | myAirMNS · Traditional | 04/08/2026SE |
| K251661 | Mariana Minerva; Mariana NimbusMNS · Traditional | 02/23/2026SE |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | 12/05/2025SE |
| K250624 | myAirBZD · Traditional | 05/28/2025SE |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask SystemBZD · Traditional | 05/19/2025SE |
| K241939 | EasyCare Tx 2BZD · Traditional | 09/27/2024SE |
| K241216 | myAirBZD · Traditional | 09/26/2024SE |
| K200565 | GalapogosBZD · Traditional | 01/17/2021SE |
| K203126 | S10 KirraBZD · Traditional | 12/18/2020SE |
| K183512 | Moore Park MaskBZD · Traditional | 05/07/2019SE |
| K180497 | Scone MaskBZD · Traditional | 06/15/2018SE |
| K172875 | Astral 100/150CBK · Traditional | 04/26/2018SE |
| K170924 | AirFit F20BZD · Traditional | 01/03/2018SE |
| K171212 | AirFit N20BZD · Traditional | 09/28/2017SE |
| K161492 | Juno VPAP ST-AMNS · Traditional | 01/19/2017SE |
| K160836 | Menai SystemBZD · Traditional | 12/15/2016SE |
| K161978 | AirFit N20BZD · Traditional | 11/17/2016SE |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP TxMNS · Traditional | 09/09/2016SE |
| K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVBZD · Traditional | 09/09/2016SE |
| K153563 | AirFit F20BZD · Traditional | 05/13/2016SE |
| K152068 | Astral 100/150CBK · Traditional | 05/13/2016SE |
| K153673 | AirFit N20BZD · Traditional | 05/02/2016SE |
| K153061 | Juno VPAP ST-AMNS · Traditional | 04/13/2016SE |
| K151901 | AirViewCBK · Traditional | 11/05/2015SE |
| K143623 | Narval BruxMQC · Traditional | 08/13/2015SE |
| K143603 | Darlinghurst Vented, Darlinghurst NV-AAVBZD · Traditional | 05/21/2015SE |
| K140279 | S9 GreenhillsBZD · Traditional | 07/31/2014SE |
| K140159 | S9 Wanda Vpap STBZD · Traditional | 06/17/2014SE |
| K132901 | Airsoft F15BZD · Traditional | 06/09/2014SE |
| K133868 | Astral VentilatorCBK · Traditional | 06/04/2014SE |
| K140054 | RescanBZD · Traditional | 05/16/2014SE |
| K140124 | S9 EloueraBZD · Traditional | 05/12/2014SE |
| K132606 | S9 Cronulla for HerBZD · Traditional | 01/13/2014SE |
| K132887 | Airfit N10BZD · Traditional | 12/20/2013SE |
| K132371 | Easycare OnlineMNS · Traditional | 11/22/2013SE |
| K132013 | Swift AirBZD · Traditional | 10/21/2013SE |
| K123789 | Swift FX NanoBZD · Traditional | 03/29/2013SE |
| K123511 | S9 Vpap TXMNS · Traditional | 03/21/2013SE |
| K123557 | Easycare OnlineMNS · Traditional | 03/14/2013SE |
| K123979 | Quattro AirBZD · Traditional | 02/27/2013SE |
| K122324 | Vpap S-AMNS · Traditional | 11/13/2012SE |
| K121705 | GeoBZD · Special | 10/23/2012SE |
| K113801 | Vpap AdaptBZD · Traditional | 05/25/2012SE |
| K113714 | Vpap TXMNS · Traditional | 05/25/2012SE |
| K113780 | Easycare TX System (Connexuns)BZD · Traditional | 04/20/2012SE |
| K113288 | Vpap St-AMNS · Traditional | 03/29/2012SE |
| K113815 | ResscanMNS · Traditional | 03/27/2012SE |
| K113127 | Mirage QuattroBZD · Special | 01/06/2012SE |
| K112914 | Vpap TXMNS · Traditional | 12/29/2011SE |
| K112489 | Swift FX BellaBZD · Special | 12/07/2011SE |
| K113201 | Narval CCLQZ · Abbreviated | 12/01/2011SE |
| K112393 | TasmanBZD · Traditional | 11/16/2011SE |
| K111148 | S8 Aspen with H4I PlusBZD · Special | 06/30/2011SE |
| K102586 | S9 Vpap Adapt with H5IBZD · Traditional | 03/18/2011SE |
| K110444 | Mirage MicroBZD · Special | 03/16/2011SE |
| K102513 | S9 Vpap ST with H5IBZD · Traditional | 01/05/2011SE |
| K102746 | Mirage FXBZD · Traditional | 12/28/2010SE |
| K102224 | Pixi Pediatric MaskBZD · Traditional | 12/10/2010SE |
| K100772 | Mirage Micro Model 16333 (S), 16334 (M&L), 16335 (LW & XL)BZD · Special | 06/09/2010SE |
| K093731 | Vpap III St-AMNS · Traditional | 03/22/2010SE |
| K093684 | Easycare OnlineBZD · Traditional | 02/26/2010SE |
| K092186 | Vpap TXMNS · Traditional | 12/22/2009SE |
| K092026 | Easycare TX, TX LinkBZD · Traditional | 10/02/2009SE |
| K091947 | S8 Aspen with H4I PlusBZD · Traditional | 09/28/2009SE |
| K091129 | Quattro LTBZD · Traditional | 08/03/2009SE |
| K090490 | Mirage EchoBZD · Traditional | 05/06/2009SE |
| K090244 | Swift FXBZD · Traditional | 04/13/2009SE |
| K083816 | Res Traxx Online, Model: R14BZD · Traditional | 03/20/2009SE |
| K082605 | Vpap Auto with Humidaire 3IBZD · Traditional | 01/13/2009SE |
| K082983 | Resscan-ProBZD · Traditional | 01/02/2009SE |
| K082979 | S8 AdvanceBZD · Traditional | 01/02/2009SE |
| K081321 | Modification to Mirage MicroBZD · Special | 10/09/2008SE |
| K080797 | Humidaire 2IBTT · Traditional | 07/09/2008SE |
| K080079 | S8 Escape IIBZD · Traditional | 04/08/2008SE |
| K080131 | Vpap STBZD · Traditional | 04/01/2008SE |
| K073638 | Swift LTBZD · Traditional | 03/20/2008SE |
| K072615 | TxcontrolBZD · Traditional | 01/04/2008SE |
| K072940 | Mirage MicroBZD · Traditional | 12/13/2007SE |
| K071808 | Mirage MicroBZD · Traditional | 10/10/2007SE |
| K070746 | Restraxx Data Centre, Model R10BZD · Traditional | 07/13/2007SE |
| K071171 | Vpap Auto with H3IBZD · Traditional | 07/10/2007SE |
| K063122 | Mirage Quattro Full Face MaskBZD · Traditional | 02/02/2007SE |
| K063011 | Mirage Liberty Full Face MaskBZD · Traditional | 02/02/2007SE |
| K062291 | Vpap Malibu with H2IBZD · Traditional | 09/08/2006SE |
| K061200 | Prestige CPAP Flow Generator with Prestige HumidifierBZD · Traditional | 07/20/2006SE |
| K060105 | Vpap III St-A/Kidsta Mask SystemMNS · Traditional | 04/07/2006SE |
| K053205 | Res Traxx Data CenterBZD · Traditional | 02/03/2006SE |
| K051364 | Vpap AdaptMNS · Traditional | 08/16/2005SE |
| K051314 | Res Traxx Data CenterBZD · Traditional | 07/15/2005SE |
| K050775 | ResscanBZD · Traditional | 05/10/2005SE |
| K050359 | Ultra Mirage II MaskBZD · Traditional | 03/16/2005SE |
| K050142 | Resmed Meridian MaskBZD · Special | 03/01/2005SE |
| K042403 | Mirage SwiftBZD · Traditional | 10/08/2004SE |
| K041362 | Resmed Hospital Full Face MaskBZD · Traditional | 07/15/2004SE |
| K041209 | Resmed S8 Pioneer CPAP SystemBZD · Traditional | 07/01/2004SE |
| K033276 | Vpap III St-AMNS · Traditional | 06/07/2004SE |
| K040944 | Rescontrol IIBZD · Traditional | 06/03/2004SE |
| K034033 | RescanBZD · Traditional | 05/05/2004SE |
| K033914 | Oxygen Diverter ValveBZD · Traditional | 04/22/2004SE |
| K040566 | Resmed Hospital Nasal MaskBZD · Special | 04/02/2004SE |
| K033841 | Resmed S8 Prime CPAP SystemBZD · Traditional | 03/10/2004SE |
| K030797 | S7 Elite CPAP System with Somnotraxx System; Autoset Spirit CPAP System with Somnotraxx…BZD · Traditional | 03/10/2004SE |
| K032916 | Mirage Activa MaskBZD · Traditional | 12/04/2003SE |
| K032433 | Nasal Jacks MaskBZD · Traditional | 10/24/2003SE |
| K032480 | Autoset Spirit SystemBZD · Traditional | 10/16/2003SE |
| K031047 | Mirage Vista MaskBZD · Traditional | 08/19/2003SE |
| K030843 | Vpap IIIBZD · Traditional | 08/15/2003SE |
| K024191 | S7 Elite and Autoset Spirit CPAP Systems with ReslinkBZD · Traditional | 07/02/2003SE |
| K030798 | Mirage Activa MaskBZD · Special | 04/09/2003SE |
| K023306 | Mirage Full Face Mask Series 2BZD · Traditional | 11/27/2002SE |
| K023284 | Mirage Full Face Mask Series 2BZD · Traditional | 11/27/2002SE |
| K023244 | Mirage Full Face Mask Series 2BZD · Traditional | 11/27/2002SE |
| K013843 | Autoset Spirit CPAP SystemBZD · Traditional | 07/16/2002SE |
| K013909 | S7 Elite CP Ap SystemBZD · Traditional | 07/08/2002SE |
| K984428 | Sullivan Autoset Nasal CPAP SystemBZD · Traditional | 07/26/1999SE |
| K982530 | Sullivan Mirage Full Face MaskBZD · Traditional | 10/16/1998SE |
| K980721 | Sullivan AutosetBZD · Traditional | 09/01/1998SE |
| K974539 | Sullivan Vpap II ST Ventilatory Support SystemMNT · Traditional | 08/06/1998SE |
| K974417 | Sullivan Vpap II St-A Nasal Vpap SystemMNS · Traditional | 06/24/1998SE |
| K971260 | Sullivan Humidaire Heated HumidifierBTT · Traditional | 09/04/1997SE |
| K970771 | Sullivan Autoset Portable II Nasal CPAP SystemBZD · Traditional | 06/20/1997SE |
| K970516 | Sullivan Autoset Home Nasal CPAP SystemBZD · Traditional | 05/09/1997SE |
| K961783 | Sullivan Vpap II ST Nasal Vpap SystemBZD · Traditional | 08/01/1996SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2735-2026 Class I | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger… | 06/25/2026Open, Classified |
| Z-0542-2024 Class I | AirFit F30i Full Face Mask and User GuideMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic… | 11/20/2023Open, Classified |
| Z-0541-2024 Class I | AirFit F30 Full Face Mask and User GuideMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic… | 11/20/2023Open, Classified |
| Z-0540-2024 Class I | AirTouch N20 Nasal Mask and User GuideMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic… | 11/20/2023Open, Classified |
| Z-0539-2024 Class I | AirFit N20 Nasal Mask and User GuideMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic… | 11/20/2023Open, Classified |
| Z-0538-2024 Class I | AirTouch F20 Full Face Mask and User GuideMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic… | 11/20/2023Open, Classified |
| Z-0537-2024 Class I | AirFit F20 Full Face Mask and User GuideMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic… | 11/20/2023Open, Classified |
| Z-0536-2024 Class I | AirFit N10 Nasal Masks and User GuideMasks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic… | 11/20/2023Open, Classified |
| Z-0111-2024 Class I | Astral 100 and Astral 150 ventilatorsIf ventilator is on internal battery, not intended to serve as a primary power source, low/critically low… | 09/13/2023Open, Classified |
| Z-0915-2020 Class I | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150Combination of software and a component failure may cause audible alarms not to operate properly, the alarm… | 12/12/2019Completed |
| Z-2550-2016 Class II | Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with…Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a… | 07/12/2016Terminated |
| Z-0746-2016 Class II | Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as…Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. | 01/13/2016Terminated |
| Z-1750-2015 Class II | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection.… | 05/05/2015Terminated |
| Z-1006-2007 | ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following…S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of… | 04/23/2007Terminated |