| S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM (K030797) | Resmed Corp | 2004-03-10 |
| RESMED S8 PRIME CPAP SYSTEM (K033841) | Resmed, Ltd. | 2004-03-10 |
| BIPAP PRO 2 BI-LEVEL SYSTEM (K032834) | Respironics, Inc. | 2004-03-04 |
| TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 (K031935) | Tiara Medical Systems, Inc. | 2004-03-03 |
| BILEVEL CPAP, MODEL 9055 SERIES (K032056) | Sunrise Medical | 2004-02-20 |
| C2 NASAL MASK (K033759) | Respironics, Inc. | 2004-02-19 |
| INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION (K031745) | Sensor Medics Corp. | 2004-02-13 |
| APEX MEDICAL CPAP RT 21XX (K022650) | Apex Medical Corp. | 2004-02-04 |
| ORACLE ORAL MASK, MODEL HC451A (K033087) | Fisher & Paykel Healthcare, Ltd. | 2004-01-14 |
| MIRAGE ACTIVA MASK (K032916) | Resmed, Ltd. | 2003-12-04 |
| MULTI-STRAP FULL FACE MASK (K023683) | Engineered Medical Systems | 2003-12-01 |
| NASAL JACKS MASK (K032433) | Resmed, Ltd. | 2003-10-24 |
| AUTOSET SPIRIT SYSTEM (K032480) | Resmed, Ltd. | 2003-10-16 |
| BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (K030985) | Vital Signs, Inc. | 2003-10-15 |
| ARABELLA NCPAP MASKS (K030563) | Hamilton Medical AG | 2003-09-09 |
| LYRA NASAL MASK (K031883) | Sensor Medics Corp. | 2003-08-25 |
| MIRAGE VISTA MASK (K031047) | Resmed, Ltd. | 2003-08-19 |
| VPAP III (K030843) | Resmed, Ltd. | 2003-08-15 |
| HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION (K014074) | Hoffrichter GmbH | 2003-07-23 |
| S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK (K024191) | Resmed, Ltd. | 2003-07-02 |
| MODIFICATION TO REMSTAR AUTO CPAP SYSTEM (K031460) | Respironics, Inc. | 2003-06-24 |
| SINGLE USE ORAL MASK, MODEL HC455A (K023670) | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 |
| FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK (K023559) | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 |
| PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US (K031470) | Tyco Healthcare Nancy | 2003-06-05 |
| 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS (K030822) | Hans Rudolph, Inc. | 2003-06-03 |
| PAPILLON MASK SET (K023068) | Map Medizintechnik Fur Arzt Und Patient GmbH | 2003-05-28 |
| MIRAGE ACTIVA MASK (K030798) | Resmed, Ltd. | 2003-04-09 |
| MODIFICATION TO NASAL-AIRE (K022465) | Innomed Technologies | 2003-03-21 |
| TWLIGHT, MODEL ISP 9600 (K022642) | Invacare Corp. | 2003-02-11 |
| PEGASUS NASAL CPAP SYSTEM (K022192) | Sensor Medics Corp. | 2003-01-24 |
| MIRAGE FULL FACE MASK SERIES 2 (K023284) | Resmed, Ltd. | 2002-11-27 |
| MIRAGE FULL FACE MASK SERIES 2 (K023306) | Resmed, Ltd. | 2002-11-27 |
| MIRAGE FULL FACE MASK SERIES 2 (K023244) | Resmed, Ltd. | 2002-11-27 |
| SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 (K022934) | Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits | 2002-11-14 |
| PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US (K020886) | Tyco Healthcare Nancy | 2002-11-01 |
| SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 (K020641) | Worldwide Medical Technologies, LLC | 2002-10-29 |
| 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT (K020759) | Hans Rudolph, Inc. | 2002-08-13 |
| AUTOSET SPIRIT CPAP SYSTEM (K013843) | Resmed Corp | 2002-07-16 |
| S7 ELITE CP AP SYSTEM (K013909) | Resmed Corp | 2002-07-08 |
| IQ NASAL MASK, MODEL 50160 REV. D (K021534) | Sleepnet Corporation | 2002-07-02 |
| REMSTAR PRO WITH C-FLEX CPAP SYSTEM (K021861) | Respironics, Inc. | 2002-06-19 |
| ORION NASAL CPAP SYSTEM (K020730) | Bird Products Corp. | 2002-05-22 |
| REMSTAR AUTO CPAP SYSTEM (K012554) | Respironics, Inc. | 2002-01-29 |
| WEINMANN SOMNOMASK (K013738) | Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits | 2002-01-22 |
| LIFEGUARD NASAL CPAP MASK AND ACCESSORIES (K013421) | Lifeguard Medical Products, Inc. | 2002-01-08 |
| MINIME NASAL MASK, MODEL P/N 50220 (K013306) | Sleepnet Corporation | 2001-11-02 |
| MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT (K012034) | Sensor Medics Corp. | 2001-07-24 |
| ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 (K012207) | Tiara Medical Systems, Inc. | 2001-07-23 |
| DEVILBISS 9000 SERIES CPAP, MODEL 9001 (K011229) | Sunrise Medical Hhg, Inc. | 2001-07-11 |
| BIPAP PRO BI-LEVEL SYSTEM (K011714) | Respironics, Inc. | 2001-06-28 |
| ORACLE ORAL MASK (K003894) | Fisher & Paykel Healthcare, Ltd. | 2001-06-25 |
| INFANT FLOW SYSTEM, MODEL M672P (K011516) | Eme (Electro Medical Equipment) , Ltd. | 2001-06-08 |
| REMREST (K002763) | Medical Industries America, Inc. | 2001-05-04 |
| DORNIR LC-1 CPAP SYSTEM (K010704) | Prym Medical , Ltd. | 2001-04-18 |
| REMSTAR PLUS CPAP SYSTEM (K010263) | Respironics, Inc. | 2001-03-29 |
| AERO-CLICK (K993094) | Map Medizintechnik Fur Arzt Und Patient GmbH | 2000-10-23 |
| RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 (K000705) | Respironics, Inc. | 2000-09-08 |
| SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 (K002465) | Respironics, Inc. | 2000-09-08 |
| BREEZE SLEEPGEAR WITH DREAMSEAL (K002001) | Puritan Bennett Corp. | 2000-09-06 |
| SANSIBAR CPAP SYSTEM (K000888) | Prym Medical , Ltd. | 2000-08-15 |
| BREAS PV 100 CPAP SYSTEM (K001553) | Vital Signs, Inc. | 2000-08-03 |
| MALLINCKRODT, GOODKNIGHT 418S (K001845) | Mallinckrodt Developpement France | 2000-07-05 |
| BIPAP DUET LX BI-LEVEL SYSTEM (K000994) | Respironics, Inc. | 2000-06-22 |
| SWIVEL ELBOW (K000215) | Engineered Medical Systems | 2000-05-26 |
| AIRPILOTMASK, MODEL TMS-900 (K992192) | Tiara Medical Systems, Inc. | 2000-05-12 |
| MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 (K993584) | Nellcor Puritan Bennett France Dvpt. | 2000-03-07 |
| HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 (K990856) | Bird Products Corp. | 2000-01-11 |
| CPAP/PRO CPAP INTERFACE (K992384) | Stevenson Industries, Inc. | 1999-12-01 |
| NASAL AIRE (K990659) | Breathing Technologies Corp. | 1999-11-26 |
| RESPIRONICS TOTAL FACE MASK (K992969) | Respironics, Inc. | 1999-11-10 |
| VIRTUOSO LX SMART CPAP SYSTEM (K993433) | Respironics, Inc. | 1999-10-27 |
| IQ NASAL MASK, MODEL P/N 50160 (K993269) | Sleepnet Corporation | 1999-10-27 |
| ARIA LX CPAP SYSTEM (K993307) | Respironics, Inc. | 1999-10-27 |
| OPAP (K991926) | Opap, Inc. | 1999-10-18 |
| INFANT FLOW SYSTEM (K991972) | Sensor Medics Corp. | 1999-08-13 |
| MONARCH II MINI MASK (K992336) | Respironics, Inc. | 1999-08-13 |
| SULLIVAN AUTOSET NASAL CPAP SYSTEM (K984428) | Resmed, Ltd. | 1999-07-26 |
| REUSABLE CONTOUR II NASAL MASK (K991648) | Respironics, Inc. | 1999-05-28 |
| NELLCOR PURITAN BENNETT, GOODKNIGHT 418G (K991150) | Nellcor Puritan Bennett France Dvpt. | 1999-04-14 |
| INFANT FLOW NCPAP MASKS (K984254) | Sensor Medics Corp. | 1999-02-24 |
| INVACARE CPAP (K982242) | Invacare Corp. | 1999-01-27 |
| SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K980551) | Nidek Medical Products, Inc. | 1998-11-17 |
| SULLIVAN MIRAGE FULL FACE MASK (K982530) | Resmed, Ltd. | 1998-10-16 |
| COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER (K981744) | W. Keith Thornton, D.D.S. | 1998-10-14 |
| SULLIVAN AUTOSET (K980721) | Resmed, Ltd. | 1998-09-01 |
| NASAL INTERFACE MODEL 7910 (K974453) | Healthdyne Technologies, Inc. | 1998-08-04 |
| GOODKNIGHT 418 CPAP SYSTEM (K980365) | Nellcor Puritan Bennett, Inc. | 1998-07-22 |
| CPAP HUMIDIFIER (HC 200) (K973161) | Fisher & Paykel Electronics , Ltd. | 1998-07-10 |
| MODEL 7410 VOYAGER (K974879) | Healthdyne Technologies, Inc. | 1998-06-29 |
| INFANT FLOW SYSTEM (K974303) | Sensor Medics Corp. | 1998-01-30 |
| EMS NASAL CPAP MASK (K972605) | Engineered Medical Systems | 1998-01-28 |
| TMS COMFORT SERIES NASAL CPAP MASK (K964092) | Tiara Medical Systems, Inc. | 1997-07-31 |
| SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM (K970771) | Resmed, Ltd. | 1997-06-20 |
| MORPHEE PLUS ALPHA (K964019) | Nellcor Puritan Bennett, Inc. | 1997-06-18 |
| SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM (K970516) | Resmed, Ltd. | 1997-05-09 |
| QUARTET CLINICAL SYSTEM (K963761) | Respironics, Inc. | 1997-04-18 |
| MODEL 1700 TRANQUILITY BILEVEL SYSTEM (K970173) | Healthdyne Technologies, Inc. | 1997-04-16 |
| NASALFLAIR (K951944) | Airways Ltd., Inc. | 1997-03-28 |
| BIPAP DUET SYSTEM (K964363) | Respironics, Inc. | 1997-01-30 |
| WHISPER SWIVEL II EXHALATION PORT (K962203) | Respironics, Inc. | 1996-12-05 |