FDA.reportPublic FDA data

RESPIRONICS INC.

Matched from indexed company URL: RESPIRONICS INC.,

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25184222518422RESPIRONICS INC.1N2026-01-011001 Murry Ridge Lane MURRYSVILLE PA US 15668

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
381681432014507K992969RESPIRONICS TOTAL FACE MASKBZD1999-11-10
381682065212743K991725SIDESTREAM NEBULIZERCAF1999-07-30
381681294573549K991648REUSABLE CONTOUR II NASAL MASKBZD1999-05-28
381681041167838K991105ECG ELECTRODE (VARIOUS)DRX1999-11-26
381681633556138K991033ACTIWATCH-SCOREGWQ1999-06-23
381681756428383K983533ACTIWATCHGWQ1999-03-23
381681053529754K982454BIPAP VISION VENTILATORY SUPPORTMNT1998-11-03
381681411042033K982293PRESSURE TRANSDUCER AIRFLOW SENSORMNR1998-07-13
381682011311460K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WHBYE1999-03-09
381681043012843K964653OASIS HUMIDIFIERBTT1997-02-14
381681736671402K963380CO 2 SMO PLUSBZC1997-01-22
381681665122676K963250PRESSURE VALVEBZD1996-11-14
381681765971878K962924PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEMBZH1996-10-25
381681270319922K962822OPTICHAMBERCAF1996-10-17
381682026622363K962203WHISPER SWIVEL II EXHALATION PORTBZD1996-12-05
381681950225934K961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICEBWF1996-07-15
381681267611680K960851THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSORBZQ1996-09-17
381681004210105K953392HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)BTT1996-03-12
381681196356221K950397SYSTEM 22 VALVEBYE1995-04-14
381681328089012K945782HUMIDIFIERBTT1996-03-01
381681011816563K944175ADAM SHELL THERMOCOUPLE ASSEMBLYBZG1994-10-14
381681529982471K940888SYSTEM 22 PAEDIATRIC MASKBYG1994-04-19
381681900260610K940015SNORING MICROPHONE, SM1MNR1995-01-11
381681034534354K940014PLM SENSOR, MODEL PLM1BZQ1994-11-10
381681785072792K940013BODY POSITION INDICATOR, MODEL BPI1MNR1995-05-04
381681702899824K933889PERSONAL BEST LOW RANGEBZH1993-09-09
381681909719107K924123SIDESTREAM DISPOSABLECAF1992-11-16
381681034132785K923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSORBZQ1992-12-30
381681788653294K915460HEATED RESPIRATORY HUMIDIFIER HC100BTT1993-01-15
381681089938887K913423LIFECARE REMOTE ALARM IICBK1992-01-30
381681432967230K913396CANNULA STYLE THERMOCOUPLESBZG1992-05-22
381681946103578K913395EZ-1 SYSTEM RESPIRATORY EFFORT SENSORSBZG1992-05-20
381681965191633K913367MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESSBTT1992-06-25
381681323729720K910947NEV-10 NEGATIVE PRESSURE VENTILATORBYT1991-06-03
381682028131891K904935RESPIRONICS' DIGITAL MANOMETERCAP1991-04-03
381681602657568K902292MODIFIED ASSESS(R) PEAK FLOW METERBZH1990-08-10
381682035280322K895849RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEMBYT1989-12-22
381681433415011K894361LIFECARE PRESSURE ALARM CAT. NO. 34-010CAP1989-10-05
381681704123537K883825MODIFIED SANDERS BI-PAPEASYBYE1988-12-08
381681515004143K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERBWF1987-03-31
381681671481864K842876PORTABLE LIFECARE VENTILATOR PLV-102CBK1984-08-29
381681808811946K810255MEAN PRESSURE MONITORCAP1981-02-12
381681262981624K243394AF531 Oro-Nasal SE Face MaskCBK2024-12-30
381681646374431K233555AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face MaskBZD2024-07-31
381681599104426K210844DreamWear Silicone Pillows MaskBZD2021-08-24
381681671503648K210386Magneto Nasal MaskBZD2021-07-12
381681170953279K202142Sleepware G3OLZ2020-10-29
381681328835241K201439Ventilator, Non-continuous (Respirator)BZD2020-09-25
381681305965160K200480DreamStation 2 System, DreamStation 2 Advanced SystemBZD2020-07-10
381681698326298K183226Care Orchestrator EssenceBZD2019-10-18
381681235570543K181170Trilogy Evo UniversalCBK2019-07-18
381681367408439K181166Trilogy EvoCBK2019-07-18
381681289296073K181053Care OrchestratorBZD2019-01-04
381681242992917K180608Lunoa SystemMYB2018-06-05
381681322846581K152356SapphireBZD2016-01-08
381681178595097K151120Simple T Pediatric Nasal MaskBZD2016-04-15
381681571900692K150639AF541 EE Full Face MaskBZD2015-09-18
381682062472064K150638AF541 SE Full Face MaskCBK2015-09-18
381681229801452K142988Sleepware G3OLZ2015-03-16
381681961907368K142554Revolution Full Face MaskBZD2015-01-09
381681980527512K140980TI NASAL MASKBZD2015-02-10
381681509951709K140424RESPIRONICS REUSABLE HEATED TUBINGBZE2014-11-14
381681776268550K140268SIMPLE T YOUTH NASAL MASKBZD2014-10-20
381681380443118K132168BRONCHOSCOPY ELBOWBZD2013-11-20
381681143798291K131982REMSTAR AUTO A-FLEX HTBZD2013-10-18
381681560342684K130077REMSTAR SEBZD2013-05-21
381681187907010K122847KANGAROO NASAL MASKBZD2013-03-06
381681538224266K122769REMSTAR SEBZD2012-10-09
381681903937992K122111RESPIRONICS SIMPLYCLEAR DEVICESDT2012-12-31
381681263239902K121955COUGHASSIST T70 DEVICENHJ2012-12-14
381681811736981K121631SIMPLE T NASAL MASKBZD2012-10-05
381681622802605K121623BIPAP A 40 VENTILATORY SUPPORT SYSTEMMNT2012-12-14
381681485822823K120639PERFORMAX PEDIATRIC SE TOTAL FACE MASKCBK2012-07-10
381681593302298K120562PERFORMAX PEDIATRIC EE TOTAL FACE MASKBZD2012-07-17
381681707032613K113068REMSTAR AUTO A-FLEX HTBZD2011-12-16
381681314408761K113053BIPAP A 30 VENTILATORY SUPPORT SYSTEMMNS2012-02-01
381682037210991K111885SIMPLYGO PORTABLE OXYGEN CONCENTRATORCAW2011-11-04
381681300041961K111610TRILOGY SERIES VENTILATOR WITH OXIMETRYCBK2011-10-14
381681587071980K111378OXIMETRY INTERFACE KITMNS2011-10-04
381681740389246K110405TRUBLUE NASAL MASKBZD2011-06-06
381681587768471K110398RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITSBZE2011-06-01
381681899501073K110293OPTICHAMBER DIAMOND VALVED HOLDING CHAMBERNVP2011-08-09
381681241574365K103395PERFORMAX TOTAL FACE MASKBZD2011-03-24
381681667980931K102985V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSMNT2011-04-05
381681518713971K102465BIPAP AVAPS VENTILATORY SUPPORT SYSTEMMNS2011-03-24
381681418529283K102454I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEMCAF2011-10-25
381681165178403K102240NIVO NEBULIZER SYSTEMCAF2010-11-10
381681834511539K101130BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASKMNS2010-09-02
381681443212431K101129ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASKCBK2010-09-16
381681329369492K100428MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETERDQA2010-07-09
381681159662292K100285LITETOUCH MASKCAF2010-06-29
381681899239281K093905TRILOGY 202 VENTILATORCBK2010-05-12
381681897398941K093416TRILOGY 200 VENTILATORCBK2010-01-29
381682035267530K092835COMFORTGEL NASAL MASKBZD2010-02-12
381681965018902K092818BIPAP AVAPS VENTILATORY SUPPORT SYSTEMMNS2010-01-22
381681028927696K092648RESPIRONICS PERFORMAX SE TOTAL FACE MASKCBK2009-12-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZD612024-07-31
CBK182024-12-30
MNR132009-06-26
CAF102011-10-25
MNS92012-02-01
BTT72008-03-31
MNT52012-12-14
CAW52011-11-04
DQA52010-07-09
GWQ52001-10-15
OLZ42020-10-29
BZE42014-11-14
BYE41999-03-09
BZH31996-10-25
BZQ31996-09-17
BZG31994-10-14
BYT31991-06-03
CAP31991-04-03
MYB22018-06-05
NHJ22012-12-14
LRK22004-02-06
BWF21996-07-15
SDT12012-12-31
NVP12011-08-09
GWK12006-09-22
CCK12005-12-13
FLL12004-04-22
MQM12001-03-19
DRX11999-11-26
BZC11997-01-22
BYG11994-04-19

PMN#