FDA 510(k) Applications Submitted by Respironics, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K140424 |
02/19/2014 |
RESPIRONICS REUSABLE HEATED TUBING |
RESPIRONICS, INC. |
K142554 |
09/11/2014 |
Revolution Full Face Mask |
Respironics, Inc. |
K183625 |
12/26/2018 |
SomnaPatch |
Respironics, Inc. |
K082558 |
09/04/2008 |
COMFORTLITE NASAL MASK |
RESPIRONICS, INC. |
K082654 |
09/12/2008 |
ENTERAL ONLY EXTENSION SET |
RESPIRONICS, INC. |
K200480 |
02/27/2020 |
DreamStation 2 System, DreamStation 2 Advanced System |
Respironics, Inc. |
K034040 |
12/29/2003 |
ESPRIT VENTILATOR, MODEL V1000 |
RESPIRONICS, INC. |
K210386 |
02/09/2021 |
Magneto Nasal Mask |
Respironics, Inc. |
K990199 |
01/21/1999 |
SMARTRECORDER, MODEL 2500 |
RESPIRONICS, INC. |
K991627 |
05/11/1999 |
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 |
RESPIRONICS, INC. |
K982550 |
07/22/1998 |
BROWSER (EVENT SOFTWARE) MODEL # 4500E |
RESPIRONICS, INC. |
K140268 |
02/12/2014 |
SIMPLE T YOUTH NASAL MASK |
RESPIRONICS, INC. |
K161411 |
05/20/2016 |
Care Cycle Connect Application |
RESPIRONICS, INC. |
K121955 |
07/03/2012 |
COUGHASSIST T70 DEVICE |
RESPIRONICS, INC. |
K132168 |
07/12/2013 |
BRONCHOSCOPY ELBOW |
RESPIRONICS, INC. |
K122111 |
07/17/2012 |
RESPIRONICS SIMPLYCLEAR DEVICE |
RESPIRONICS, INC. |
K131994 |
06/28/2013 |
SOMNOLYZER 24X7 |
RESPIRONICS, INC. |
K142988 |
10/16/2014 |
Sleepware G3 |
RESPIRONICS, INC. |
K010052 |
01/08/2001 |
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER |
RESPIRONICS, INC. |
K010263 |
01/29/2001 |
REMSTAR PLUS CPAP SYSTEM |
RESPIRONICS, INC. |
K990574 |
02/23/1999 |
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 |
RESPIRONICS, INC. |
K000705 |
03/02/2000 |
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 |
RESPIRONICS, INC. |
K000994 |
03/28/2000 |
BIPAP DUET LX BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
K991648 |
05/13/1999 |
REUSABLE CONTOUR II NASAL MASK |
RESPIRONICS, INC. |
K011714 |
06/04/2001 |
BIPAP PRO BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
K992336 |
07/13/1999 |
MONARCH II MINI MASK |
RESPIRONICS, INC. |
K012323 |
07/23/2001 |
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K992530 |
07/28/1999 |
BIPAP SYNCHRONY HC |
RESPIRONICS, INC. |
K012554 |
08/08/2001 |
REMSTAR AUTO CPAP SYSTEM |
RESPIRONICS, INC. |
K002465 |
08/11/2000 |
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 |
RESPIRONICS, INC. |
K012633 |
08/13/2001 |
RESPIRONICS HEATED HUMIDIFIER |
RESPIRONICS, INC. |
K992969 |
09/03/1999 |
RESPIRONICS TOTAL FACE MASK |
RESPIRONICS, INC. |
K993307 |
10/04/1999 |
ARIA LX CPAP SYSTEM |
RESPIRONICS, INC. |
K993433 |
10/12/1999 |
VIRTUOSO LX SMART CPAP SYSTEM |
RESPIRONICS, INC. |
K003499 |
11/13/2000 |
REMVIEW SLEEP RECORDER, MODEL 320 |
RESPIRONICS, INC. |
K984407 |
12/09/1998 |
BIPAP HARMONY S/T, MODEL 1001445 |
RESPIRONICS, INC. |
K951264 |
03/21/1995 |
BIPAP MODEL S/T-D |
RESPIRONICS, INC. |
K982454 |
07/15/1998 |
BIPAP VISION VENTILATORY SUPPORT |
RESPIRONICS, INC. |
K121623 |
06/01/2012 |
BIPAP A 40 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K102465 |
08/27/2010 |
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K113053 |
10/13/2011 |
BIPAP A 30 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K963550 |
09/05/1996 |
RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM |
RESPIRONICS, INC. |
K963250 |
08/19/1996 |
PRESSURE VALVE |
RESPIRONICS, INC. |
K961626 |
04/26/1996 |
SOLO CPAP SYSTEM |
RESPIRONICS, INC. |
K961915 |
05/17/1996 |
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE |
RESPIRONICS, INC. |
K962203 |
06/07/1996 |
WHISPER SWIVEL II EXHALATION PORT |
RESPIRONICS, INC. |
K972829 |
07/30/1997 |
CRICKET 2000 RECORDING PULSE OXIMETER |
RESPIRONICS, INC. |
K963761 |
09/18/1996 |
QUARTET CLINICAL SYSTEM |
RESPIRONICS, INC. |
K973875 |
10/10/1997 |
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM |
RESPIRONICS, INC. |
K964363 |
11/01/1996 |
BIPAP DUET SYSTEM |
RESPIRONICS, INC. |
K955324 |
11/20/1995 |
BIPAP S/T-D 30 SYSTEM |
RESPIRONICS, INC. |
K964653 |
11/20/1996 |
OASIS HUMIDIFIER |
RESPIRONICS, INC. |
K130077 |
01/14/2013 |
REMSTAR SE |
RESPIRONICS, INC. |
K122769 |
09/10/2012 |
REMSTAR SE |
RESPIRONICS, INC. |
K113068 |
10/17/2011 |
REMSTAR AUTO A-FLEX HT |
RESPIRONICS, INC. |
K201439 |
06/01/2020 |
Ventilator, Non-continuous (Respirator) |
Respironics, Inc. |
K202142 |
07/31/2020 |
Sleepware G3 |
Respironics, Inc. |
K093905 |
12/22/2009 |
TRILOGY 202 VENTILATOR |
RESPIRONICS, INC. |
K110398 |
02/11/2011 |
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS |
RESPIRONICS, INC. |
K111610 |
06/09/2011 |
TRILOGY SERIES VENTILATOR WITH OXIMETRY |
RESPIRONICS, INC. |
K001208 |
04/14/2000 |
ESPIRT |
RESPIRONICS, INC. |
K041568 |
06/10/2004 |
EOCD |
RESPIRONICS, INC. |
K110008 |
01/03/2011 |
GOLIFE NASAL MASK |
RESPIRONICS, INC. |
K110405 |
02/14/2011 |
TRUBLUE NASAL MASK |
RESPIRONICS, INC. |
K120562 |
02/24/2012 |
PERFORMAX PEDIATRIC EE TOTAL FACE MASK |
RESPIRONICS, INC. |
K120639 |
03/02/2012 |
PERFORMAX PEDIATRIC SE TOTAL FACE MASK |
RESPIRONICS, INC. |
K121631 |
06/04/2012 |
SIMPLE T NASAL MASK |
RESPIRONICS, INC. |
K131982 |
06/28/2013 |
REMSTAR AUTO A-FLEX HT |
RESPIRONICS, INC. |
K102502 |
09/01/2010 |
GOLIFE NASAL MASK |
RESPIRONICS, INC. |
K103395 |
11/19/2010 |
PERFORMAX TOTAL FACE MASK |
RESPIRONICS, INC. |
K981072 |
03/24/1998 |
ESPRIT VENTILATOR |
RESPIRONICS, INC. |
K973920 |
10/15/1997 |
STARDUST |
RESPIRONICS, INC. |
K953341 |
05/09/1995 |
ARIA CPAP SYSTEM |
RESPIRONICS, INC. |
K953930 |
08/21/1995 |
VIRTUOSO SMART CPAP SYSTEM |
RESPIRONICS, INC. |
K954207 |
09/07/1995 |
GEL MASK |
RESPIRONICS, INC. |
K954572 |
10/02/1995 |
MAESTRO CLINICAL REMOTE CONTROL |
RESPIRONICS, INC. |
K945782 |
11/25/1994 |
HUMIDIFIER |
RESPIRONICS, INC. |
K945938 |
12/05/1994 |
RESPIRONICS MONARCH MINI MASK |
RESPIRONICS, INC. |
K150639 |
03/11/2015 |
AF541 EE Full Face Mask |
RESPIRONICS, INC. |
K150638 |
03/11/2015 |
AF541 SE Full Face Mask |
Respironics, Inc. |
K140980 |
04/16/2014 |
TI NASAL MASK |
RESPIRONICS, INC. |
K151120 |
04/27/2015 |
Simple T Pediatric Nasal Mask |
RESPIRONICS, INC. |
K210844 |
03/22/2021 |
DreamWear Silicone Pillows Mask |
Respironics, Inc. |
K983071 |
09/02/1998 |
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER |
RESPIRONICS, INC. |
K050414 |
02/18/2005 |
PLIX |
RESPIRONICS, INC. |
K021845 |
06/05/2002 |
STARDUST II, MODEL 1011176 |
RESPIRONICS, INC. |
K092043 |
07/06/2009 |
BIPAP SYNCHRONY 2 |
RESPIRONICS, INC. |
K093416 |
11/02/2009 |
TRILOGY 200 VENTILATOR |
RESPIRONICS, INC. |
K030090 |
01/10/2003 |
H2 HEATED HUMIDIFIER |
RESPIRONICS, INC. |
K040044 |
01/12/2004 |
HEEL SNUGGLER, MODEL 99047 |
RESPIRONICS, INC. |
K040595 |
03/08/2004 |
ALICE 5 |
RESPIRONICS, INC. |
K020777 |
03/11/2002 |
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX |
RESPIRONICS, INC. |
K050759 |
03/24/2005 |
BIPAP AUTO |
RESPIRONICS, INC. |
K060919 |
04/04/2006 |
ACTICAL |
RESPIRONICS, INC. |
K091028 |
04/10/2009 |
OMNI 5 TOTAL O2 DELIVERY SYSTEM |
RESPIRONICS, INC. |
K061034 |
04/14/2006 |
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
K091112 |
04/17/2009 |
RESPIRONICS SLEEPEASY CPAP SYSTEM |
RESPIRONICS, INC. |
K041010 |
04/20/2004 |
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM |
RESPIRONICS, INC. |
K101130 |
04/22/2010 |
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK |
RESPIRONICS, INC. |
K101129 |
04/22/2010 |
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK |
RESPIRONICS, INC. |
K081206 |
04/29/2008 |
HOMELOX |
RESPIRONICS, INC. |
K061256 |
05/04/2006 |
SMARTMONITOR 2PS |
RESPIRONICS, INC. |
K061261 |
05/05/2006 |
L4 OXYGEN CONCENTRATOR |
RESPIRONICS, INC. |
K031460 |
05/08/2003 |
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM |
RESPIRONICS, INC. |
K031656 |
05/28/2003 |
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K021861 |
06/06/2002 |
REMSTAR PRO WITH C-FLEX CPAP SYSTEM |
RESPIRONICS, INC. |
K081779 |
06/23/2008 |
GOLOX-93 |
RESPIRONICS, INC. |
K061870 |
07/03/2006 |
VITALSENSE XHR |
RESPIRONICS, INC. |
K032403 |
08/04/2003 |
SMARTMONITOR 2 PROFESSIONAL SERIES (PS) |
RESPIRONICS, INC. |
K052110 |
08/04/2005 |
M-SERIES PRO CPAP SYTEM |
RESPIRONICS, INC. |
K032834 |
09/11/2003 |
BIPAP PRO 2 BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
K052489 |
09/12/2005 |
ACTIHEART |
RESPIRONICS, INC. |
K092818 |
09/14/2009 |
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
K052573 |
09/19/2005 |
STARDUST II |
RESPIRONICS, INC. |
K023135 |
09/20/2002 |
IMAGE3 SE DISPOSABLE FULL FACE MASK |
RESPIRONICS, INC. |
K072723 |
09/26/2007 |
RESPIRONICS GOLOX |
RESPIRONICS, INC. |
K072996 |
10/24/2007 |
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM |
RESPIRONICS, INC. |
K043006 |
11/01/2004 |
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 |
RESPIRONICS, INC. |
K063533 |
11/22/2006 |
BIPAP SYNCHRONY |
RESPIRONICS, INC. |
K063540 |
11/24/2006 |
BIPAP AUTOSV |
RESPIRONICS, INC. |
K033759 |
12/02/2003 |
C2 NASAL MASK |
RESPIRONICS, INC. |
K053352 |
12/02/2005 |
COMFORTLITE NASAL MASK |
RESPIRONICS, INC. |
K033822 |
12/10/2003 |
RESPIRONICS CUSTOM I ORAL APPLIANCE |
RESPIRONICS, INC. |
K033823 |
12/10/2003 |
RESPIRONICS CUSTOM II ORAL APPLIANCE |
RESPIRONICS, INC. |
K043607 |
12/30/2004 |
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX |
RESPIRONICS, INC. |
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