Data / Medical devices / Australia / Resmed Pty Ltd.
Resmed Pty Ltd.: FDA-registered device maker in BELLA VISTA New South Wales, Australia, 64 510(k) clearances
Resmed Pty Ltd. is registered with the FDA (registration 3004604967) in BELLA VISTA New South Wales, Australia. It lists 18 device types. The FDA files 64 510(k) clearances under its listings, the newest dated February 23, 2026. 5 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004604967
- Address
- 1 Elizabeth Macarthur Drive, BELLA VISTA New South Wales, Australia, 2153
- Owner or operator
- RESMED CORP. (9002319)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- June 18, 2004
- Registered through
- 2026
- Brand names listed
- Air tubing connector, AirFit F20, F20 QuietAir Elbow, RPSII, S8 CPAP System, S8 VPAP System, SULLIVAN NASAL CPAP SYSTEM, VPAP ST, H4i
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2026 | K251661 | Mariana Minerva; Mariana Nimbus | MNS | Substantially Equivalent | Resmed Pty , Ltd. | accessdata.fda.gov |
| May 19, 2025 | K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | BZD | Substantially Equivalent | Resmed Pty , Ltd. | accessdata.fda.gov |
| September 24, 2024 | K234134 | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | BZD | Substantially Equivalent | Resmed Pty Ltd (Registration Number: 3004604967) | accessdata.fda.gov |
| October 19, 2023 | K230476 | Oran Park Mask | BZD | Substantially Equivalent | Resmed Pty Ltd (Registration Number: 3004604967) | accessdata.fda.gov |
| July 6, 2023 | K223747 | Whitsundays Mask System | BZD | Substantially Equivalent | Resmed Pty Ltd (Registration Number: 3004604967) | accessdata.fda.gov |
| December 18, 2020 | K203126 | S10 Kirra | BZD | Substantially Equivalent | Resmed Pty , Ltd. | accessdata.fda.gov |
| May 7, 2019 | K183512 | Moore Park Mask | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| June 15, 2018 | K180497 | Scone Mask | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 26, 2018 | K172875 | Astral 100/150 | CBK | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| January 3, 2018 | K170924 | AirFit F20 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| September 28, 2017 | K171212 | AirFit N20 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| January 19, 2017 | K161492 | Juno VPAP ST-A | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| December 15, 2016 | K160836 | Menai System | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| November 17, 2016 | K161978 | AirFit N20 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| May 13, 2016 | K153563 | AirFit F20 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| May 13, 2016 | K152068 | Astral 100/150 | CBK | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| May 2, 2016 | K153673 | AirFit N20 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 13, 2016 | K153061 | Juno VPAP ST-A | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| May 21, 2015 | K143603 | Darlinghurst Vented, Darlinghurst NV-AAV | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 30, 2015 | K143272 | ApneaLink Air | MNR | Substantially Equivalent | Resmed Germany, Inc. | accessdata.fda.gov |
| July 31, 2014 | K140279 | S9 GREENHILLS | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| June 17, 2014 | K140159 | S9 WANDA VPAP ST | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| June 4, 2014 | K133868 | ASTRAL VENTILATOR | CBK | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| May 12, 2014 | K140124 | S9 ELOUERA | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| December 20, 2013 | K132887 | AIRFIT N10 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| November 8, 2013 | K131932 | APNEALINK PRO | MNR | Substantially Equivalent | Resmed Germany, Inc. | accessdata.fda.gov |
| October 21, 2013 | K132013 | SWIFT AIR | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| June 17, 2013 | K122715 | STELLAR 150 | MNT | Substantially Equivalent | Resmed Germany, Inc. | accessdata.fda.gov |
| March 29, 2013 | K123789 | SWIFT FX NANO | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| March 21, 2013 | K123511 | S9 VPAP TX | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| February 27, 2013 | K123979 | QUATTRO AIR | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| November 13, 2012 | K122324 | VPAP S-A | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 20, 2012 | K113780 | EASYCARE TX SYSTEM (CONNEXUNS) | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 5, 2012 | K113640 | STELLAR 150 | MNT | Substantially Equivalent | Resmed Germany, Inc. | accessdata.fda.gov |
| March 29, 2012 | K113288 | VPAP ST-A | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| January 6, 2012 | K113127 | MIRAGE QUATTRO | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| December 7, 2011 | K112489 | SWIFT FX BELLA | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| June 30, 2011 | K111148 | S8 ASPEN WITH H4I PLUS | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| March 18, 2011 | K102586 | S9 VPAP ADAPT WITH H5I | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| March 1, 2011 | K103167 | STELLAR 150 | MNT | Substantially Equivalent | Resmed Germany, Inc. | accessdata.fda.gov |
| January 5, 2011 | K102513 | S9 VPAP ST WITH H5I | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| December 28, 2010 | K102746 | MIRAGE FX | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| March 22, 2010 | K093731 | VPAP III ST-A | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| December 22, 2009 | K092186 | VPAP TX | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| September 28, 2009 | K091947 | S8 ASPEN WITH H4I PLUS | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| August 3, 2009 | K091129 | QUATTRO LT | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| May 6, 2009 | K090490 | MIRAGE ECHO | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| April 13, 2009 | K090244 | SWIFT FX | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 1, 2008 | K080131 | VPAP ST | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| March 20, 2008 | K073638 | SWIFT LT | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| December 13, 2007 | K072940 | MIRAGE MICRO | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| July 10, 2007 | K071171 | VPAP AUTO WITH H3I | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| February 2, 2007 | K063011 | MIRAGE LIBERTY FULL FACE MASK | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 7, 2006 | K060105 | VPAP III ST-A/KIDSTA MASK SYSTEM | MNS | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| March 16, 2005 | K050359 | ULTRA MIRAGE II MASK | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| October 8, 2004 | K042403 | MIRAGE SWIFT | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| July 15, 2004 | K041362 | RESMED HOSPITAL FULL FACE MASK | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| July 1, 2004 | K041209 | RESMED S8 PIONEER CPAP SYSTEM | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 2, 2004 | K040566 | RESMED HOSPITAL NASAL MASK | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| December 4, 2003 | K032916 | MIRAGE ACTIVA MASK | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| August 19, 2003 | K031047 | MIRAGE VISTA MASK | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| November 27, 2002 | K023306 | MIRAGE FULL FACE MASK SERIES 2 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| July 26, 1999 | K984428 | SULLIVAN AUTOSET NASAL CPAP SYSTEM | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| August 1, 1996 | K961783 | SULLIVAN VPAP II ST NASAL VPAP SYSTEM | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | 99304 | Class I | Ongoing | 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 ventilation. | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy. | accessdata.fda.gov |
| November 20, 2023 | 93499 | Class I | Ongoing | AirFit N10 Nasal Masks and User Guide | Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using m | accessdata.fda.gov |
| September 13, 2023 | 93122 | Class I | Ongoing | Astral 100 and Astral 150 ventilators | If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sou | accessdata.fda.gov |
| December 12, 2019 | 84551 | Class I | Completed | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power withou | accessdata.fda.gov |
| May 5, 2015 | 71100 | Class II | Terminated | 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. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Ventilator, Continuous, Non-Life-Supporting
- All makers of Mask, Gas, Anesthetic
- All makers of Tubing, Pressure And Accessories
- All makers of Cannula, Nasal, Oxygen
- All makers of Protector, Skin Pressure
Updated July 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.