510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ResMed Corp

BELLA VISTA New South Wales, AU

RESMED CORP appears in FDA device records in BELLA VISTA New South Wales, AU. FDA records list 123 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
123
PMA records
0
Recall records
14
Registered establishments
3

510(k) clearance history

Showing 50 of 123

FDA records hold 123 510(k) clearances for ResMed Corp between 1996 and 2026. The busiest year on record is 2004, with 10. The most recent is 2026, with 4.

Clearances by year, as a table
510(k) clearance decisions for ResMed Corp, by decision year
YearClearances
19961
19973
19984
19991
20025
20037
200410
20055
20064
20076
20086
200910
20105
20117
20128
20137
20147
20152
20168
20172
20183
20191
20201
20211
20242
20253
20264
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253553OrionBZDSubstantially Equivalent
K254104ResScan EssentialsBZDSubstantially Equivalent
K251889myAirMNSSubstantially Equivalent
K251661Mariana Minerva; Mariana NimbusMNSSubstantially Equivalent
K251657Personalized Therapy Comfort Settings (PTCS)BZDSubstantially Equivalent
K250624myAirBZDSubstantially Equivalent
K242547AirFit F20 Mask System; AirFit F20 NM Mask SystemBZDSubstantially Equivalent
K241939EasyCare Tx 2BZDSubstantially Equivalent
K241216myAirBZDSubstantially Equivalent
K200565GalapogosBZDSubstantially Equivalent
K203126S10 KirraBZDSubstantially Equivalent
K183512Moore Park MaskBZDSubstantially Equivalent
K180497Scone MaskBZDSubstantially Equivalent
K172875Astral 100/150CBKSubstantially Equivalent
K170924AirFit F20BZDSubstantially Equivalent
K171212AirFit N20BZDSubstantially Equivalent
K161492Juno VPAP ST-AMNSSubstantially Equivalent
K160836Menai SystemBZDSubstantially Equivalent
K161978AirFit N20BZDSubstantially Equivalent
K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxMNSSubstantially Equivalent
K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVBZDSubstantially Equivalent
K153563AirFit F20BZDSubstantially Equivalent
K152068Astral 100/150CBKSubstantially Equivalent
K153673AirFit N20BZDSubstantially Equivalent
K153061Juno VPAP ST-AMNSSubstantially Equivalent
K151901AirViewCBKSubstantially Equivalent
K143603Darlinghurst Vented, Darlinghurst NV-AAVBZDSubstantially Equivalent
K140279S9 GREENHILLSBZDSubstantially Equivalent
K140159S9 WANDA VPAP STBZDSubstantially Equivalent
K132901AIRSOFT F15BZDSubstantially Equivalent
K133868ASTRAL VENTILATORCBKSubstantially Equivalent
K140054RESCANBZDSubstantially Equivalent
K140124S9 ELOUERABZDSubstantially Equivalent
K132606S9 CRONULLA FOR HERBZDSubstantially Equivalent
K132887AIRFIT N10BZDSubstantially Equivalent
K132371EASYCARE ONLINEMNSSubstantially Equivalent
K132013SWIFT AIRBZDSubstantially Equivalent
K123789SWIFT FX NANOBZDSubstantially Equivalent
K123511S9 VPAP TXMNSSubstantially Equivalent
K123557EASYCARE ONLINEMNSSubstantially Equivalent
K123979QUATTRO AIRBZDSubstantially Equivalent
K122324VPAP S-AMNSSubstantially Equivalent
K121705GEOBZDSubstantially Equivalent
K113801VPAP ADAPTBZDSubstantially Equivalent
K113714VPAP TXMNSSubstantially Equivalent
K113780EASYCARE TX SYSTEM (CONNEXUNS)BZDSubstantially Equivalent
K113288VPAP ST-AMNSSubstantially Equivalent
K113815RESSCANMNSSubstantially Equivalent
K113127MIRAGE QUATTROBZDSubstantially Equivalent
K112914VPAP TXMNSSubstantially Equivalent

Registered establishments

FDA registered establishments for ResMed Corp, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30075734691000115734RESMED CORP9001 Spectrum Center Boulevard, San Diego, CA 92123 US2026and 10 more, listed in full below
30046049673004604967RESMED PTY LTD.1 ELIZABETH MACARTHUR DRIVE, BELLA VISTA New South Wales 2153 AU2026and 8 more, listed in full below
30112057103011205710ResMed Corp600 Riverside Parkway Suite 100, Lithia Spgs, GA 30122 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2735-2026Resmed 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.Class IOpen, Classified
Z-0542-2024AirFit F30i Full Face Mask and User GuideMasks 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 masks or anyone in close physical contactClass IOpen, Classified
Z-0541-2024AirFit F30 Full Face Mask and User GuideMasks 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 masks or anyone in close physical contactClass IOpen, Classified
Z-0540-2024AirTouch N20 Nasal Mask and User GuideMasks 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 masks or anyone in close physical contactClass IOpen, Classified
Z-0539-2024AirFit N20 Nasal Mask and User GuideMasks 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 masks or anyone in close physical contactClass IOpen, Classified
Z-0538-2024AirTouch F20 Full Face Mask and User GuideMasks 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 masks or anyone in close physical contactClass IOpen, Classified
Z-0537-2024AirFit F20 Full Face Mask and User GuideMasks 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 masks or anyone in close physical contactClass IOpen, Classified
Z-0536-2024AirFit N10 Nasal Masks and User GuideMasks 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 masks or anyone in close physical contactClass IOpen, Classified
Z-0111-2024Astral 100 and Astral 150 ventilatorsIf 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 sound for less than 2 minutes or not at allClass IOpen, Classified
Z-0915-2020ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150Combination 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 without pressing the power switch.Class ICompleted
Z-2550-2016Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilatorsMasks 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.Class IITerminated
Z-0746-2016Astral 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 device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.Class IITerminated
Z-1750-2015Astral 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.Class IITerminated
Z-1006-2007ResMed 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).Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain