Data / Medical devices / United States / Resmed Corp
Resmed Corp: FDA-registered device maker in San Diego, CA, United States, 76 510(k) clearances
Resmed Corp is registered with the FDA (registration 3007573469) in San Diego, CA, United States. It lists 21 device types. The FDA files 76 510(k) clearances under its listings, the newest dated August 27, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007573469
- FEI number
- 1000115734
- Address
- 9001 Spectrum Center Boulevard, San Diego, CA, United States, 92123
- Owner or operator
- RESMED CORP. (9002319)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 18, 2004
- Registered through
- 2026
- Brand names listed
- Air tubing connector, Aria, Nightowl, 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 |
|---|---|---|---|---|---|---|
| August 27, 2026 | K261360 | EasyCare Tx 2 | MOD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| June 4, 2026 | K253553 | Orion | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| May 27, 2026 | K254104 | ResScan Essentials | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| April 8, 2026 | K251889 | myAir | MNS | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| February 23, 2026 | K251661 | Mariana Minerva; Mariana Nimbus | MNS | Substantially Equivalent | Resmed Pty , Ltd. | accessdata.fda.gov |
| December 5, 2025 | K251657 | Personalized Therapy Comfort Settings (PTCS) | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| September 27, 2024 | K241939 | EasyCare Tx 2 | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| September 26, 2024 | K241216 | myAir | BZD | Substantially Equivalent | Resmed Corp | 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 |
| February 24, 2022 | K220028 | NightOwl | MNR | Substantially Equivalent | Ectosense NV | accessdata.fda.gov |
| January 17, 2021 | K200565 | Galapogos | BZD | Substantially Equivalent | Resmed Corp | accessdata.fda.gov |
| December 18, 2020 | K203126 | S10 Kirra | BZD | Substantially Equivalent | Resmed Pty , Ltd. | accessdata.fda.gov |
| April 3, 2020 | K200564 | Aria System | JOW | Substantially Equivalent | Inova Labs | 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 |
| November 5, 2015 | K151901 | AirView | CBK | 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 6, 2014 | K132205 | ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM | CAW | Substantially Equivalent | Inova Labs, Inc. | accessdata.fda.gov |
| June 4, 2014 | K133868 | ASTRAL VENTILATOR | CBK | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| May 16, 2014 | K140054 | RESCAN | BZD | 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 |
| 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 |
| 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 28, 2011 | K113317 | LIFECHOICE OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Inova Labs, Inc. | 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 |
| December 10, 2010 | K102224 | PIXI PEDIATRIC MASK | 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 |
| January 11, 2008 | K072688 | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 | CAW | Substantially Equivalent | International Biophysics Corp. | 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 |
|---|---|---|---|---|---|---|
| July 12, 2016 | 74736 | Class II | Terminated | Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators | Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask. | accessdata.fda.gov |
| January 13, 2016 | 73071 | Class II | Terminated | 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 primarily using the | Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. | accessdata.fda.gov |
| April 23, 2007 | 37832 | Not yet classified | Terminated | 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, #33007. | S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke). | accessdata.fda.gov |
Compare with other makers
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Updated August 27, 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.