| RESSCAN-PRO (K082983) | Resmed, Ltd. | 2009-01-02 |
| DEVILBISS DV5M SMARTLINK SYSTEM (K082209) | Sunrise Medical | 2008-10-28 |
| MODIFICATION TO MIRAGE MICRO (K081321) | Resmed, Ltd. | 2008-10-09 |
| PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST (K082237) | Mallinckrodt Developpement France | 2008-10-09 |
| SLEEPSTYLE 200 AUTO SERIES HC254 (K081029) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK (K080209) | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 |
| LAMIN AIR (K080516) | Remgenic, LLC | 2008-06-23 |
| SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE (K080439) | Mallinckrodt Developpement France | 2008-05-16 |
| CPAP MASK (K071915) | Arcimed Laboratories, LLC | 2008-05-14 |
| SOYALA GEL VENTED (K081014) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-05-09 |
| COMFORTGEL FULL FACE MASK (K073600) | Respironics Inc., Sleep & Home Respiratory Group | 2008-04-25 |
| S8 ESCAPE II (K080079) | Resmed, Ltd. | 2008-04-08 |
| VPAP ST (K080131) | Resmed, Ltd. | 2008-04-01 |
| SOYALA FULL FACE MASK GEL VENTED (K073673) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-03-28 |
| SWIFT LT (K073638) | Resmed, Ltd. | 2008-03-20 |
| REUSABLE HEADREST WITH NASAL SEAL (K072993) | Aeiomed, Inc. | 2008-02-08 |
| HRI 6500, 6600 AND 6700 SERIES V2MASKS (K071149) | Hans Rudolph, Inc. | 2008-02-01 |
| TXCONTROL (K072615) | Resmed, Ltd. | 2008-01-04 |
| REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM (K072996) | Respironics, Inc. | 2007-12-27 |
| PERFORMAX TOTAL FACE MASK (K072592) | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-19 |
| WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 (K072009) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-12-14 |
| MIRAGE MICRO (K072940) | Resmed, Ltd. | 2007-12-13 |
| GALEMED CPAP MASK (K072755) | Galemed Corp. | 2007-11-16 |
| MIRAGE MICRO (K071808) | Resmed, Ltd. | 2007-10-10 |
| CPAP NASAL MASK WITH PILLOWS (K071773) | Lifesource | 2007-09-12 |
| SANDMAN INTRO (K071575) | Mallinckrodt Developpement France | 2007-09-10 |
| DEVILBISS INTELLIPAP MODEL DV 5 SERIES (K071689) | Sunrise Medical | 2007-09-07 |
| WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 (K071163) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-07-18 |
| RESTRAXX DATA CENTRE, MODEL R10 (K070746) | Resmed, Ltd. | 2007-07-13 |
| VPAP AUTO WITH H3I (K071171) | Resmed, Ltd. | 2007-07-10 |
| MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY (K071069) | Viasys Sleep Systems, LLC | 2007-06-12 |
| APEX MEDICAL XT1 CPAP, MODEL 9S-005 (K070609) | Apex Medical Corp. | 2007-05-04 |
| TWILIGHT FULL FACE MASK (K070321) | Invacare Corp. | 2007-04-30 |
| KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US (K063501) | Mallinckrodt Developpement France | 2007-04-06 |
| REMSTAR AFLEX CPAP SYSTEM (K063830) | Respironics Inc., Sleep & Home Respiratory Group | 2007-03-09 |
| CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 (K063268) | Hsiner Co., Ltd. | 2007-02-23 |
| MIRAGE QUATTRO FULL FACE MASK (K063122) | Resmed, Ltd. | 2007-02-02 |
| MIRAGE LIBERTY FULL FACE MASK (K063011) | Resmed, Ltd. | 2007-02-02 |
| BREAS ISLEEP 20I (K063476) | Breas Medical AB | 2007-01-22 |
| OPUS HC482 DIRECT NASAL MASK (K063036) | Fisher & Paykel Healthcare, Ltd. | 2006-12-22 |
| SOYALA FULL FACE MASK (K061653) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006-11-09 |
| VPAP MALIBU WITH H2I (K062291) | Resmed, Ltd. | 2006-09-08 |
| INVACARE'S TWILIGHT II NASAL MASKS (K061874) | Invacare Corp. | 2006-09-05 |
| FLEXIFIT HC432 FULL FACE MASK (K061236) | Fisher & Paykel Healthcare, Ltd. | 2006-08-29 |
| ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. (K060657) | Breas Medical AB | 2006-08-18 |
| RESPCARE HYBRID AV MASK (K062224) | Respcare, Inc. | 2006-08-17 |
| BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 (K061099) | Hoffman Laboratories, LLC | 2006-08-11 |
| PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER (K061200) | Resmed, Ltd. | 2006-07-20 |
| MASKMEDIC CONCEPT NASAL MASK (K060067) | Maskmedic | 2006-07-14 |
| BIPAP PLUS M-SERIES BI-LEVEL SYSTEM (K061034) | Respironics, Inc. | 2006-06-23 |
| BREAS ISLEEP 20+ (K061057) | Breas Medical AB | 2006-06-23 |
| SOYALA, SOYALA BLUE (K060405) | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006-06-21 |
| SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 (K060273) | Sleepnet Corporation | 2006-05-02 |
| COMFORTLITE NASAL MASK (K053352) | Respironics, Inc. | 2006-02-15 |
| RES TRAXX DATA CENTER (K053205) | Resmed, Ltd. | 2006-02-03 |
| TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET (K053486) | Hoffrichter GmbH | 2006-01-04 |
| BREATHEX OMEGA CPAP DEVICE, MODEL 322 (K052597) | Hoffman Laboratories, LLC | 2005-12-16 |
| UTOPIA (K052249) | Respcare, Inc. | 2005-12-07 |
| AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER (K051226) | Cardinalhealth | 2005-11-17 |
| TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 (K051583) | Tiara Medical Systems, Inc. | 2005-11-04 |
| RESPCARE FACE MASK (K052227) | Respcare, Inc. | 2005-10-28 |
| M-SERIES PRO CPAP SYTEM (K052110) | Respironics, Inc. | 2005-10-20 |
| AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K050994) | Cardinalhealth | 2005-08-03 |
| RES TRAXX DATA CENTER (K051314) | Resmed, Ltd. | 2005-07-15 |
| IMASK, MODELS 100, 200 AND 300 (K051559) | Vital Signs Colorado, Inc. | 2005-07-08 |
| BIPAP AUTO (K050759) | Respironics, Inc. | 2005-06-15 |
| GOODKNIGHT 425ST (K050072) | Nellcor Puritan Bennett, Inc. | 2005-06-13 |
| CPAP HUMIDIFIER, MODEL HC238JHU (K050904) | Fisher & Paykel Healthcare, Ltd. | 2005-05-25 |
| RESSCAN (K050775) | Resmed, Ltd. | 2005-05-10 |
| PIONEER U121 SERIES CPAP (K041823) | Merits Health Products Co., Ltd. | 2005-05-10 |
| IT NASAL MASK (K050171) | Innomed Technologies | 2005-05-04 |
| ULTRA MIRAGE II MASK (K050359) | Resmed, Ltd. | 2005-03-16 |
| AURA CPAP SYSTEM (K042945) | Aeiomed, Inc. | 2005-03-09 |
| SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM (K040202) | Salter Labs | 2005-03-04 |
| RESMED MERIDIAN MASK (K050142) | Resmed, Ltd. | 2005-03-01 |
| DEVILBISS AUTOADJUST, MODEL 9054 SERIES (K043282) | Sunrise Medical | 2005-02-11 |
| BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX (K043607) | Respironics, Inc. | 2005-01-28 |
| TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 (K043382) | Tiara Medical Systems, Inc. | 2005-01-19 |
| DEVILBISS NASAL CPAP MASK, 9354 SERIES (K042455) | Sunrise Medical | 2005-01-14 |
| MIRAGE SWIFT (K042403) | Resmed, Ltd. | 2004-10-08 |
| SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) (K042294) | Suiter Enterprises, Inc. | 2004-09-10 |
| AURA CPAP PATIENT INTERFACE (K042130) | Aeiomed, Inc. | 2004-09-08 |
| HC604 CPAP HUMIDIFIER (K041900) | Fisher & Paykel Healthcare, Ltd. | 2004-08-31 |
| APEX MEDICAL CPAP MODEL 9S-003 (K041828) | Apex Medical Corp. | 2004-07-30 |
| GOODKNIGHT 425, MODELM-114500-00 (K041819) | Mallinckrodt Developpement France | 2004-07-22 |
| RESMED HOSPITAL FULL FACE MASK (K041362) | Resmed, Ltd. | 2004-07-15 |
| RESMED S8 PIONEER CPAP SYSTEM (K041209) | Resmed, Ltd. | 2004-07-01 |
| IMASK TM (K041309) | Vital Signs, Inc. | 2004-06-30 |
| GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM (K040862) | Caradyne, Ltd. | 2004-06-30 |
| TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 (K034053) | Tiara Medical Systems, Inc. | 2004-06-24 |
| CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) (K040941) | Fisher & Paykel Healthcare, Ltd. | 2004-06-10 |
| HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND (K041035) | Hoffrichter GmbH | 2004-06-09 |
| RESCONTROL II (K040944) | Resmed, Ltd. | 2004-06-03 |
| VENTLAB NASAL CPAP CANNULA (K040726) | Ventlab Corp. | 2004-06-03 |
| FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A (K040506) | Fisher & Paykel Healthcare, Ltd. | 2004-05-05 |
| RESCAN (K034033) | Resmed, Ltd. | 2004-05-05 |
| REMSTAR AUTO WITH C-FLEX CPAP SYSTEM (K041010) | Respironics, Inc. | 2004-05-05 |
| OXYGEN DIVERTER VALVE (K033914) | Resmed, Ltd. | 2004-04-22 |
| RESMED HOSPITAL NASAL MASK (K040566) | Resmed, Ltd. | 2004-04-02 |
| INVACARE POLARIS EX CPAP, MODEL ISP3000 (K031064) | Invacare Corp. | 2004-03-12 |