FDA.reportPublic FDA data

RESMED CORP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075734691000115734RESMED CORP1Y2026-01-019001 Spectrum Center Boulevard San Diego CA US 92123
30112057103011205710ResMed Corp1Y2026-01-01600 Riverside Parkway Suite 100 Lithia Spgs GA US 30122

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1015791194118649K984428SULLIVAN AUTOSET NASAL CPAP SYSTEMBZD1999-07-26
1015791685607997K961783SULLIVAN VPAP II ST NASAL VPAP SYSTEMBZD1996-08-01
1015791274474500K261360EasyCare Tx 2MOD2026-08-27
1015791545391756K254104ResScan EssentialsBZD2026-05-27
1015792008464280K253553OrionBZD2026-06-04
1015791309590871K251889myAirMNS2026-04-08
1015792069382066K251661Mariana Minerva; Mariana NimbusMNS2026-02-23
1015791667100394K251657Personalized Therapy Comfort Settings (PTCS)BZD2025-12-05
1015791130731977K241939EasyCare Tx 2BZD2024-09-27
1015791768531164K241216myAirBZD2024-09-26
1015791924125193K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemBZD2024-09-24
1015791475280107K230476Oran Park MaskBZD2023-10-19
1015791367798296K220028NightOwlMNR2022-02-24
1015791558832341K203126S10 KirraBZD2020-12-18
1015791688952818K200565GalapogosBZD2021-01-17
1015791627869952K200564Aria SystemJOW2020-04-03
1015792056652443K183512Moore Park MaskBZD2019-05-07
1015791138158284K180497Scone MaskBZD2018-06-15
1015791483821880K172875Astral 100/150CBK2018-04-26
1015792049858372K171212AirFit N20BZD2017-09-28
1015791033221944K170924AirFit F20BZD2018-01-03
1015791397150670K161978AirFit N20BZD2016-11-17
1015791441837889K161492Juno VPAP ST-AMNS2017-01-19
1015791960806420K160836Menai SystemBZD2016-12-15
1015791177362491K153673AirFit N20BZD2016-05-02
1015791519521336K153563AirFit F20BZD2016-05-13
1015792061228260K153061Juno VPAP ST-AMNS2016-04-13
1015791286910236K152068Astral 100/150CBK2016-05-13
1015791298224757K151901AirViewCBK2015-11-05
1015791756959924K143603Darlinghurst Vented, Darlinghurst NV-AAVBZD2015-05-21
1015792037230504K143272ApneaLink AirMNR2015-04-30
1015791873397802K140279S9 GREENHILLSBZD2014-07-31
1015791591373970K140159S9 WANDA VPAP STBZD2014-06-17
1015791439023676K140124S9 ELOUERABZD2014-05-12
1015791437469262K140054RESCANBZD2014-05-16
1015791856215600K133868ASTRAL VENTILATORCBK2014-06-04
1015791450117624K132887AIRFIT N10BZD2013-12-20
1015792031536152K132371EASYCARE ONLINEMNS2013-11-22
1015791521652490K132205ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEMCAW2014-06-06
1015791841125675K132013SWIFT AIRBZD2013-10-21
1015791374094236K123789SWIFT FX NANOBZD2013-03-29
1015791608530166K123511S9 VPAP TXMNS2013-03-21
1015792000287705K122715STELLAR 150MNT2013-06-17
1015791466884958K122324VPAP S-AMNS2012-11-13
1015791138220490K113780EASYCARE TX SYSTEM (CONNEXUNS)BZD2012-04-20
1015791112048222K113714VPAP TXMNS2012-05-25
1015791085948649K113640STELLAR 150MNT2012-04-05
1015791751314334K113317LIFECHOICE OXYGEN CONCENTRATORCAW2011-12-28
1015791143755059K113288VPAP ST-AMNS2012-03-29
1015791379260229K113127MIRAGE QUATTROBZD2012-01-06
1015791861004543K112914VPAP TXMNS2011-12-29
1015791569142828K112489SWIFT FX BELLABZD2011-12-07
1015791378192407K111148S8 ASPEN WITH H4I PLUSBZD2011-06-30
1015791179495509K103167STELLAR 150MNT2011-03-01
1015791288363342K102746MIRAGE FXBZD2010-12-28
1015791302600627K102586S9 VPAP ADAPT WITH H5IBZD2011-03-18
1015791895672128K102513S9 VPAP ST WITH H5IBZD2011-01-05
1015792033285655K102224PIXI PEDIATRIC MASKBZD2010-12-10
1015791441010496K093731VPAP III ST-AMNS2010-03-22
1015791243172442K092186VPAP TXMNS2009-12-22
1015791520855923K091947S8 ASPEN WITH H4I PLUSBZD2009-09-28
1015791870115846K091129QUATTRO LTBZD2009-08-03
1015791200250660K090490MIRAGE ECHOBZD2009-05-06
1015791669564388K090244SWIFT FXBZD2009-04-13
1015791533465791K080131VPAP STBZD2008-04-01
1015791543181528K073638SWIFT LTBZD2008-03-20
1015791730954488K072940MIRAGE MICROBZD2007-12-13
1015792049252080K072688LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000CAW2008-01-11
1015791692868947K071171VPAP AUTO WITH H3IBZD2007-07-10
1015791801191435K063011MIRAGE LIBERTY FULL FACE MASKBZD2007-02-02
1015791702404339K060105VPAP III ST-A/KIDSTA MASK SYSTEMMNS2006-04-07
1015791336250306K050359ULTRA MIRAGE II MASKBZD2005-03-16
1015791745819187K042403MIRAGE SWIFTBZD2004-10-08
1015791616773832K041362RESMED HOSPITAL FULL FACE MASKBZD2004-07-15
1015791014772869K041209RESMED S8 PIONEER CPAP SYSTEMBZD2004-07-01
1015791737194333K040566RESMED HOSPITAL NASAL MASKBZD2004-04-02
1015791565153570K032916MIRAGE ACTIVA MASKBZD2003-12-04
1015791499253684K031047MIRAGE VISTA MASKBZD2003-08-19
1015791245881609K023306MIRAGE FULL FACE MASK SERIES 2BZD2002-11-27
1748721033221944
1015791044796922
1748721098933778
1015791098933778
1748721138158284
1015791159116240
1015791195330398
1015791198681730
1015791253492208
1748721286910236
1748721302600627
1015791354256292
1748721439023676
1748721519521336
1748721520855923
1748721558832341
1015791581152181
1748721591373970
1748721608530166
1015791709304652
1748721751314334
1748721870115846
1748721873397802
1748721895672128
1015792002555070
1015792069801204

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD522026-06-04
MNS132026-04-08
CBK42018-04-26
CAW32014-06-06
MNT32013-06-17
MNR22022-02-24
MOD12026-08-27
JOW12020-04-03

PMN#