FDA Product Code
FDA Product Code BZD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5905
510(k) Clearances — 462 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K082983 | RESSCAN-PRO | Resmed, Ltd. | 2009-01-02 | Traditional | PDF ↗ |
| K082979 | S8 ADVANCE | Resmed, Ltd. | 2009-01-02 | Traditional | PDF ↗ |
| K082209 | DEVILBISS DV5M SMARTLINK SYSTEM | Sunrise Medical | 2008-10-28 | Traditional | PDF ↗ |
| K082237 | PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST | Mallinckrodt Developpement France | 2008-10-09 | Special | PDF ↗ |
| K081321 | MODIFICATION TO MIRAGE MICRO | Resmed, Ltd. | 2008-10-09 | Special | PDF ↗ |
| K080209 | FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 | Traditional | PDF ↗ |
| K081029 | SLEEPSTYLE 200 AUTO SERIES HC254 | Fisher & Paykel Healthcare, Ltd. | 2008-09-12 | Traditional | PDF ↗ |
| K080516 | LAMIN AIR | Remgenic, LLC | 2008-06-23 | Traditional | PDF ↗ |
| K080439 | SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE | Mallinckrodt Developpement France | 2008-05-16 | Special | PDF ↗ |
| K071915 | CPAP MASK | Arcimed Laboratories, LLC | 2008-05-14 | Traditional | PDF ↗ |
| K081014 | SOYALA GEL VENTED | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-05-09 | Special | PDF ↗ |
| K073600 | COMFORTGEL FULL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2008-04-25 | Traditional | PDF ↗ |
| K080079 | S8 ESCAPE II | Resmed, Ltd. | 2008-04-08 | Traditional | PDF ↗ |
| K080131 | VPAP ST | Resmed, Ltd. | 2008-04-01 | Traditional | PDF ↗ |
| K073673 | SOYALA FULL FACE MASK GEL VENTED | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008-03-28 | Special | PDF ↗ |
| K073638 | SWIFT LT | Resmed, Ltd. | 2008-03-20 | Traditional | PDF ↗ |
| K072993 | REUSABLE HEADREST WITH NASAL SEAL | Aeiomed, Inc. | 2008-02-08 | Abbreviated | PDF ↗ |
| K071149 | HRI 6500, 6600 AND 6700 SERIES V2MASKS | Hans Rudolph, Inc. | 2008-02-01 | Traditional | PDF ↗ |
| K072615 | TXCONTROL | Resmed, Ltd. | 2008-01-04 | Traditional | PDF ↗ |
| K072996 | REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM | Respironics, Inc. | 2007-12-27 | Special | PDF ↗ |
| K072592 | PERFORMAX TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2007-12-19 | Traditional | PDF ↗ |
| K072009 | WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-12-14 | Traditional | PDF ↗ |
| K072940 | MIRAGE MICRO | Resmed, Ltd. | 2007-12-13 | Traditional | PDF ↗ |
| K072755 | GALEMED CPAP MASK | Galemed Corp. | 2007-11-16 | Traditional | PDF ↗ |
| K071808 | MIRAGE MICRO | Resmed, Ltd. | 2007-10-10 | Traditional | PDF ↗ |
| K071773 | CPAP NASAL MASK WITH PILLOWS | Lifesource | 2007-09-12 | Traditional | PDF ↗ |
| K071575 | SANDMAN INTRO | Mallinckrodt Developpement France | 2007-09-10 | Traditional | PDF ↗ |
| K071689 | DEVILBISS INTELLIPAP MODEL DV 5 SERIES | Sunrise Medical | 2007-09-07 | Traditional | PDF ↗ |
| K071163 | WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2007-07-18 | Traditional | PDF ↗ |
| K070746 | RESTRAXX DATA CENTRE, MODEL R10 | Resmed, Ltd. | 2007-07-13 | Traditional | PDF ↗ |
| K071171 | VPAP AUTO WITH H3I | Resmed, Ltd. | 2007-07-10 | Traditional | PDF ↗ |
| K071069 | MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY | Viasys Sleep Systems, LLC | 2007-06-12 | Traditional | PDF ↗ |
| K070609 | APEX MEDICAL XT1 CPAP, MODEL 9S-005 | Apex Medical Corp. | 2007-05-04 | Special | PDF ↗ |
| K070321 | TWILIGHT FULL FACE MASK | Invacare Corp. | 2007-04-30 | Traditional | PDF ↗ |
| K063501 | KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US | Mallinckrodt Developpement France | 2007-04-06 | Traditional | PDF ↗ |
| K063830 | REMSTAR AFLEX CPAP SYSTEM | Respironics Inc., Sleep & Home Respiratory Group | 2007-03-09 | Special | PDF ↗ |
| K063268 | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 | Hsiner Co., Ltd. | 2007-02-23 | Traditional | PDF ↗ |
| K063011 | MIRAGE LIBERTY FULL FACE MASK | Resmed, Ltd. | 2007-02-02 | Traditional | PDF ↗ |
| K063122 | MIRAGE QUATTRO FULL FACE MASK | Resmed, Ltd. | 2007-02-02 | Traditional | PDF ↗ |
| K063476 | BREAS ISLEEP 20I | Breas Medical AB | 2007-01-22 | Special | PDF ↗ |
| K063036 | OPUS HC482 DIRECT NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2006-12-22 | Traditional | PDF ↗ |
| K061653 | SOYALA FULL FACE MASK | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006-11-09 | Traditional | PDF ↗ |
| K062291 | VPAP MALIBU WITH H2I | Resmed, Ltd. | 2006-09-08 | Traditional | PDF ↗ |
| K061874 | INVACARE'S TWILIGHT II NASAL MASKS | Invacare Corp. | 2006-09-05 | Traditional | PDF ↗ |
| K061236 | FLEXIFIT HC432 FULL FACE MASK | Fisher & Paykel Healthcare, Ltd. | 2006-08-29 | Traditional | PDF ↗ |
| K060657 | ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. | Breas Medical AB | 2006-08-18 | Special | PDF ↗ |
| K062224 | RESPCARE HYBRID AV MASK | Respcare, Inc. | 2006-08-17 | Special | PDF ↗ |
| K061099 | BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 | Hoffman Laboratories, LLC | 2006-08-11 | Traditional | PDF ↗ |
| K061200 | PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER | Resmed, Ltd. | 2006-07-20 | Traditional | PDF ↗ |
| K060067 | MASKMEDIC CONCEPT NASAL MASK | Maskmedic | 2006-07-14 | Traditional | PDF ↗ |
| K061057 | BREAS ISLEEP 20+ | Breas Medical AB | 2006-06-23 | Special | PDF ↗ |
| K061034 | BIPAP PLUS M-SERIES BI-LEVEL SYSTEM | Respironics, Inc. | 2006-06-23 | Special | PDF ↗ |
| K060405 | SOYALA, SOYALA BLUE | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006-06-21 | Traditional | PDF ↗ |
| K060273 | SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 | Sleepnet Corporation | 2006-05-02 | Traditional | PDF ↗ |
| K053352 | COMFORTLITE NASAL MASK | Respironics, Inc. | 2006-02-15 | Traditional | PDF ↗ |
| K053205 | RES TRAXX DATA CENTER | Resmed, Ltd. | 2006-02-03 | Traditional | PDF ↗ |
| K053486 | TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET | Hoffrichter GmbH | 2006-01-04 | Special | PDF ↗ |
| K052597 | BREATHEX OMEGA CPAP DEVICE, MODEL 322 | Hoffman Laboratories, LLC | 2005-12-16 | Traditional | PDF ↗ |
| K052249 | UTOPIA | Respcare, Inc. | 2005-12-07 | Traditional | PDF ↗ |
| K051226 | AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER | Cardinalhealth | 2005-11-17 | Traditional | PDF ↗ |
| K051583 | TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 | Tiara Medical Systems, Inc. | 2005-11-04 | Special | PDF ↗ |
| K052227 | RESPCARE FACE MASK | Respcare, Inc. | 2005-10-28 | Traditional | PDF ↗ |
| K052110 | M-SERIES PRO CPAP SYTEM | Respironics, Inc. | 2005-10-20 | Special | PDF ↗ |
| K050994 | AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | Cardinalhealth | 2005-08-03 | Traditional | PDF ↗ |
| K051314 | RES TRAXX DATA CENTER | Resmed, Ltd. | 2005-07-15 | Traditional | PDF ↗ |
| K051559 | IMASK, MODELS 100, 200 AND 300 | Vital Signs Colorado, Inc. | 2005-07-08 | Special | PDF ↗ |
| K050759 | BIPAP AUTO | Respironics, Inc. | 2005-06-15 | Traditional | PDF ↗ |
| K050072 | GOODKNIGHT 425ST | Nellcor Puritan Bennett, Inc. | 2005-06-13 | Special | PDF ↗ |
| K050904 | CPAP HUMIDIFIER, MODEL HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005-05-25 | Traditional | PDF ↗ |
| K050775 | RESSCAN | Resmed, Ltd. | 2005-05-10 | Traditional | PDF ↗ |
| K041823 | PIONEER U121 SERIES CPAP | Merits Health Products Co., Ltd. | 2005-05-10 | Traditional | PDF ↗ |
| K050171 | IT NASAL MASK | Innomed Technologies | 2005-05-04 | Traditional | PDF ↗ |
| K050359 | ULTRA MIRAGE II MASK | Resmed, Ltd. | 2005-03-16 | Traditional | PDF ↗ |
| K042945 | AURA CPAP SYSTEM | Aeiomed, Inc. | 2005-03-09 | Abbreviated | PDF ↗ |
| K040202 | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM | Salter Labs | 2005-03-04 | Traditional | PDF ↗ |
| K050142 | RESMED MERIDIAN MASK | Resmed, Ltd. | 2005-03-01 | Special | PDF ↗ |
| K043282 | DEVILBISS AUTOADJUST, MODEL 9054 SERIES | Sunrise Medical | 2005-02-11 | Traditional | PDF ↗ |
| K043607 | BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX | Respironics, Inc. | 2005-01-28 | Special | PDF ↗ |
| K043382 | TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 | Tiara Medical Systems, Inc. | 2005-01-19 | Traditional | PDF ↗ |
| K042455 | DEVILBISS NASAL CPAP MASK, 9354 SERIES | Sunrise Medical | 2005-01-14 | Traditional | PDF ↗ |
| K042403 | MIRAGE SWIFT | Resmed, Ltd. | 2004-10-08 | Traditional | PDF ↗ |
| K042294 | SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) | Suiter Enterprises, Inc. | 2004-09-10 | Traditional | PDF ↗ |
| K042130 | AURA CPAP PATIENT INTERFACE | Aeiomed, Inc. | 2004-09-08 | Abbreviated | PDF ↗ |
| K041900 | HC604 CPAP HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2004-08-31 | Traditional | PDF ↗ |
| K041828 | APEX MEDICAL CPAP MODEL 9S-003 | Apex Medical Corp. | 2004-07-30 | Special | PDF ↗ |
| K041819 | GOODKNIGHT 425, MODELM-114500-00 | Mallinckrodt Developpement France | 2004-07-22 | Special | PDF ↗ |
| K041362 | RESMED HOSPITAL FULL FACE MASK | Resmed, Ltd. | 2004-07-15 | Traditional | PDF ↗ |
| K041209 | RESMED S8 PIONEER CPAP SYSTEM | Resmed, Ltd. | 2004-07-01 | Traditional | PDF ↗ |
| K040862 | GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM | Caradyne, Ltd. | 2004-06-30 | Traditional | PDF ↗ |
| K041309 | IMASK TM | Vital Signs, Inc. | 2004-06-30 | Traditional | PDF ↗ |
| K034053 | TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 | Tiara Medical Systems, Inc. | 2004-06-24 | Traditional | PDF ↗ |
| K040941 | CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) | Fisher & Paykel Healthcare, Ltd. | 2004-06-10 | Traditional | PDF ↗ |
| K041035 | HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND | Hoffrichter GmbH | 2004-06-09 | Traditional | PDF ↗ |
| K040944 | RESCONTROL II | Resmed, Ltd. | 2004-06-03 | Traditional | PDF ↗ |
| K040726 | VENTLAB NASAL CPAP CANNULA | Ventlab Corp. | 2004-06-03 | Traditional | PDF ↗ |
| K040506 | FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A | Fisher & Paykel Healthcare, Ltd. | 2004-05-05 | Traditional | PDF ↗ |
| K034033 | RESCAN | Resmed, Ltd. | 2004-05-05 | Traditional | PDF ↗ |
| K041010 | REMSTAR AUTO WITH C-FLEX CPAP SYSTEM | Respironics, Inc. | 2004-05-05 | Special | PDF ↗ |
| K033914 | OXYGEN DIVERTER VALVE | Resmed, Ltd. | 2004-04-22 | Traditional | PDF ↗ |
| K040566 | RESMED HOSPITAL NASAL MASK | Resmed, Ltd. | 2004-04-02 | Special | PDF ↗ |
Product code BZD · Class II · Anesthesiology. Data: openFDA.