RESMED CORP

FDA Device Registration & Listing · San Diego, CA, US · Registration 3007573469

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007573469
FEI Number
1000115734
Entity Name
RESMED CORP
City/State/Country
San Diego, CA, US
Establishment Address
9001 Spectrum Center Boulevard, San Diego, CA 92123, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
RESMED CORP. (Owner Number: 9002319)
Owner / Operator Contact Address
9001 Spectrum Center Blvd, --, San Diego, CA 92123, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K091947
PMA Number
N/A

All Registered Proprietary Names

Air tubing connector SULLIVAN NASAL CPAP SYSTEM Nightowl Aria S8 CPAP System S8 VPAP System RPSII

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2018-07-09
JAY Support, Breathing Tube Anesthesiology Class 1 868.5280 2016-09-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2015-07-09
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2016-07-18
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2016-07-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2021-01-12
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-08-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-04-20
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2013-02-06
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2018-07-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-12-11
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2012-02-22
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-02-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-05-13
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2014-05-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2012-05-25
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-15
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2016-11-14
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2004-06-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-11
OUG Medical Device Data System General Hospital Class 1 880.6310 2013-07-28
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2012-06-11
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2013-03-17
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2011-09-20
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2022-03-23
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-08-21
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2013-07-04
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2007-01-25
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2011-01-30
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2014-12-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-07-26
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-11-17
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2023-06-30
BRY Cabinet, Table And Tray, Anesthesia Anesthesiology Class 1 868.6100 2010-02-21
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-11-10
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2020-11-10
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-03-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-12-14
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2014-06-05
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2014-06-05
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-06-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-07-07
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2017-06-12
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2016-12-15
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-12-15
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-01-06
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 2016-09-02
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-12-04
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2018-07-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2019-05-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-08-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2009-06-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-11
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2014-05-27
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2014-05-27
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2014-05-27
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-05-27
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-08-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2013-04-02
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2023-06-01
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2016-04-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2021-04-02
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2018-06-20
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2013-03-24
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2010-04-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-03-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2013-10-28
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-09-25
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2026-03-17
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2026-03-17
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2014-08-04
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2010-08-19
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2015-12-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2009-11-05

Official Correspondent

David Lanfranchi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RESMED CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017684630 ResMed Asia Pte. Ltd. Singapore South West, SG
3011205710 ResMed Corp Lithia Spgs, GA, US
3007009701 ResMed West Coast Warehouse Moreno Valley, CA, US
3038236812 ResMed Malaysia Operations Sdn Bhd Senai Johor, MY
3030970580 RMO Johor Bahru, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K792722 Novametrix Medical Systems, Inc. NOVAMETRIX CPAP NASAL CANNULA 1980-01-24
K082979 Resmed, Ltd. S8 ADVANCE 2009-01-02
K203126 Resmed Pty , Ltd. S10 Kirra 2020-12-18
K003939 Invacare Corp. VENTURE HOME FILL II, MODEL IOH 200 2001-03-21
K942357 Healthdyne, Inc. H-500 ALLIANCE OXYGEN CONCENTRATOR 1994-05-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0038-2007 Sunrise Medical 2
DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number Establishment Name Location
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3017684630 ResMed Asia Pte. Ltd. Singapore South West, SG
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007573469. Last updated year: 2026. Please use registration number 3007573469 when referencing this establishment in official correspondence.
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