FDA.report

RESPIRONICS, INC.

Matched from indexed company URL: Respironics, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30027974423002797442RESPIRONICS, INC.1Y2026-01-01174 Tech Center Drive Mount Pleasant PA US 15666
30072205213007220521RESPIRONICS, INC.1N2026-01-01312 Alvin Drive New Kensington PA US 15068
30275538863027553886Respironics, Inc.1N2026-01-01Coyol Free Zone and Business Park, Building B37 Coyol Alajuela CR 20101
30072232383007223238Respironics, Inc.1N2020-04-25920 SW Emkay Drive, Suite 100 Bend OR US 97702
30090152093009015209Respironics, Inc., LA Service Center1N2020-04-2514101 Rosecrans Avenue, Unit F La Mirada CA US 90638

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
381742065212743K991725SIDESTREAM NEBULIZERCAF1999-07-30
381741411042033K982293PRESSURE TRANSDUCER AIRFLOW SENSORMNR1998-07-13
381741270319922K962822OPTICHAMBERCAF1996-10-17
381741950225934K961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICEBWF1996-07-15
381741909719107K924123SIDESTREAM DISPOSABLECAF1992-11-16
929321456947492K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMILQ1991-09-27
381741456947492K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMILQ1991-09-27
2166661323729720K910947NEV-10 NEGATIVE PRESSURE VENTILATORBYT1991-06-03
2166662035280322K895849RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEMBYT1989-12-22
2166661669559768K870962GESCO ASPIRATORBSY1987-05-22
381741515004143K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERBWF1987-03-31
2166661671481864K842876PORTABLE LIFECARE VENTILATOR PLV-102CBK1984-08-29
2166661576428855K832467PORTABLE LIFECARE VENTILATOR PLV-100CBK1983-10-20
3186421599104426K210844DreamWear Silicone Pillows MaskBZD2021-08-24
381741671503648K210386Magneto Nasal MaskBZD2021-07-12
929321305965160K200480DreamStation 2 System, DreamStation 2 Advanced SystemBZD2020-07-10
381741235570543K181170Trilogy Evo UniversalCBK2019-07-18
381741367408439K181166Trilogy EvoCBK2019-07-18
3186421961907368K142554Revolution Full Face MaskBZD2015-01-09
3186421980527512K140980TI NASAL MASKBZD2015-02-10
381741980527512K140980TI NASAL MASKBZD2015-02-10
381741776268550K140268SIMPLE T YOUTH NASAL MASKBZD2014-10-20
381741143798291K131982REMSTAR AUTO A-FLEX HTBZD2013-10-18
929321143798291K131982REMSTAR AUTO A-FLEX HTBZD2013-10-18
929321560342684K130077REMSTAR SEBZD2013-05-21
381741187907010K122847KANGAROO NASAL MASKBZD2013-03-06
381741538224266K122769REMSTAR SEBZD2012-10-09
929321538224266K122769REMSTAR SEBZD2012-10-09
3186421811736981K121631SIMPLE T NASAL MASKBZD2012-10-05
381741811736981K121631SIMPLE T NASAL MASKBZD2012-10-05
381741622802605K121623BIPAP A 40 VENTILATORY SUPPORT SYSTEMMNT2012-12-14
381741707032613K113068REMSTAR AUTO A-FLEX HTBZD2011-12-16
2166661707032613K113068REMSTAR AUTO A-FLEX HTBZD2011-12-16
929321707032613K113068REMSTAR AUTO A-FLEX HTBZD2011-12-16
381741314408761K113053BIPAP A 30 VENTILATORY SUPPORT SYSTEMMNS2012-02-01
929322037210991K111885SIMPLYGO PORTABLE OXYGEN CONCENTRATORCAW2011-11-04
381741587768471K110398RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITSBZE2011-06-01
381741899501073K110293OPTICHAMBER DIAMOND VALVED HOLDING CHAMBERNVP2011-08-09
929321518713971K102465BIPAP AVAPS VENTILATORY SUPPORT SYSTEMMNS2011-03-24
381741159662292K100285LITETOUCH MASKCAF2010-06-29
381741899239281K093905TRILOGY 202 VENTILATORCBK2010-05-12
2166661897398941K093416TRILOGY 200 VENTILATORCBK2010-01-29
381741897398941K093416TRILOGY 200 VENTILATORCBK2010-01-29
3186422035267530K092835COMFORTGEL NASAL MASKBZD2010-02-12
381742035267530K092835COMFORTGEL NASAL MASKBZD2010-02-12
929321965018902K092818BIPAP AVAPS VENTILATORY SUPPORT SYSTEMMNS2010-01-22
381741965018902K092818BIPAP AVAPS VENTILATORY SUPPORT SYSTEMMNS2010-01-22
381741792832854K092043BIPAP SYNCHRONY 2MNS2009-08-05
929321275429875K091319REMSTAR AUTO A-FLEXBZD2009-08-03
929321653708524K091112RESPIRONICS SLEEPEASY CPAP SYSTEMBZD2009-05-15
929321751863410K090539BIPAP AUTOSV ADVANCEDMNS2009-10-30
381741751863410K090539BIPAP AUTOSV ADVANCEDMNS2009-10-30
381741505410816K090484ALICE PDXMNR2009-06-26
381741725208571K083874GALAXYMNR2009-01-26
381741301059571K083526TRILOGY 100 VENTILATORCBK2009-03-13
381741594016126K082866REVOLUTIONFULL FACE MASKBZD2009-01-30
381741222031268K062689SIDESTREAM PLUSCAF2007-02-16
2166661499939105K061261L4 OXYGEN CONCENTRATORCAW2006-06-28
2166681089862999K060919ACTICALGWK2006-09-22
381741042080886K060404AG-PLUS, MODEL 91210CAF2006-06-22
381741669464079K052573STARDUST IIMNR2005-12-13
381741520760995K051383THE INCOURAGE SYSTEMBYI2005-06-17
2166661506477453K043615OXYTEC, MODEL 900CAW2005-02-09
2166661982445671K043006MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605CAW2005-02-11
381742059128678K042655INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456CAF2004-10-13
381742008438643K040595ALICE 5OLZ2004-03-18
381741040155602K032809HOSPITAL SPACERCAF2003-11-13
381741177357976K023135IMAGE3 SE DISPOSABLE FULL FACE MASKCBK2003-01-03
381741633027361K010263REMSTAR PLUS CPAP SYSTEMBZD2001-03-29
21666813991123411969-12-31
21666813991123411969-12-31
21666813991123411969-12-31
21666813991123411969-12-31
381741422444878
929321713899733

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
BZD242021-08-24
CBK92019-07-18
CAF82010-06-29
MNS72012-02-01
CAW42011-11-04
MNR42009-06-26
BWF21996-07-15
ILQ21991-09-27
BYT21991-06-03
MNT12012-12-14
NVP12011-08-09
BZE12011-06-01
GWK12006-09-22
BYI12005-06-17
OLZ12004-03-18
BSY11987-05-22

PMA

PMN

Applications

GUDID

BiPAP

2021-05-28

Respironics, Inc.

BiPAP

2021-03-19

Respironics, Inc.