Medical Device Manufacturer · US , Poway , CA

ResMed Corp

14 submissions · 14 cleared · Since 1997
14
Total
14
Cleared
0
Denied

ResMed Corp — FDA 510(k) Submissions

ResMed Corp has submitted 14 FDA 510(k) premarket notifications since 1997, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Non-continuous (respirator), Humidifier, Respiratory Gas, (direct Patient Interface), Ventilator, Continuous, Non-life-supporting . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Personalized Therapy Comfort Settings (PTCS)
K251657 · BZD Ventilator,... · Anesthesiology
Dec 2025 189d
myAir
K250624 · BZD Ventilator,... · Anesthesiology
May 2025 86d
EasyCare Tx 2
K241939 · BZD Ventilator,... · Anesthesiology
Sep 2024 87d
myAir
K241216 · BZD Ventilator,... · Anesthesiology
Sep 2024 148d
Galapogos
K200565 · BZD Ventilator,... · Anesthesiology
Jan 2021 319d
S9 ELOUERA
K140124 · BZD Ventilator,... · Anesthesiology
May 2014 116d
VPAP ADAPT
K113801 · BZD Ventilator,... · Anesthesiology
May 2012 155d
S8 ASPEN WITH H4I PLUS
K111148 · BZD Ventilator,... · Anesthesiology
Jun 2011 69d
MIRAGE ECHO
K090490 · BZD Ventilator,... · Anesthesiology
May 2009 70d
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
K030797 · BZD Ventilator,... · Anesthesiology
Mar 2004 363d
AUTOSET SPIRIT CPAP SYSTEM
K013843 · BZD Ventilator,... · Anesthesiology
Jul 2002 238d
S7 ELITE CP AP SYSTEM
K013909 · BZD Ventilator,... · Anesthesiology
Jul 2002 224d
SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
K974417 · MNS Ventilator, Continuous,... · Anesthesiology
Jun 1998 212d
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
K971260 · BTT Humidifier, Respiratory... · Anesthesiology
Sep 1997 153d
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