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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