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 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | 3B Medical, Inc. | 2013-12-23 | Traditional | PDF ↗ |
| K132887 | AIRFIT N10 | Resmed, Ltd. | 2013-12-20 | Traditional | PDF ↗ |
| K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP | 3B Medical, Inc. | 2013-12-06 | Special | PDF ↗ |
| K131702 | K SERIES CPAP SYSTEMS | Curative Medical, Inc. | 2013-12-06 | Traditional | PDF ↗ |
| K132168 | BRONCHOSCOPY ELBOW | Respironics, Inc. | 2013-11-20 | Traditional | PDF ↗ |
| K132013 | SWIFT AIR | Resmed, Ltd. | 2013-10-21 | Traditional | PDF ↗ |
| K131982 | REMSTAR AUTO A-FLEX HT | Respironics, Inc. | 2013-10-18 | Special | PDF ↗ |
| K132127 | TRANSCEND AUTO | Somnetics International, Inc. | 2013-10-17 | Traditional | PDF ↗ |
| K130686 | NASAL COMFORT FREEDOM | Lakeview Sleep Center | 2013-10-16 | Traditional | PDF ↗ |
| K131502 | SEATTLE - PAP | Seattle Childrens Hospital | 2013-10-11 | Traditional | PDF ↗ |
| K130663 | BESTFIT2 NASAL MASK | Curative Medical, Inc. | 2013-09-27 | Traditional | PDF ↗ |
| K131707 | 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS | 3B Medical, Inc. | 2013-08-22 | Special | PDF ↗ |
| K121642 | WIZARD 230 NASAL PILOW MASK | Apex Medical Corp. | 2013-06-06 | Traditional | PDF ↗ |
| K130328 | F&P SIMPLUS FULL FACE MASK | Fisher & Paykel Healthcare Limited | 2013-06-05 | Traditional | PDF ↗ |
| K130481 | SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK | Circadiance, LLC | 2013-05-24 | Traditional | PDF ↗ |
| K130077 | REMSTAR SE | Respironics, Inc. | 2013-05-21 | Traditional | PDF ↗ |
| K130037 | BREATHE CPAP SYSTEM | Breathe Technologies, Inc. | 2013-05-17 | Traditional | PDF ↗ |
| K123789 | SWIFT FX NANO | Resmed, Ltd. | 2013-03-29 | Traditional | PDF ↗ |
| K121747 | FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS | Intersurgical Incorporated | 2013-03-14 | Traditional | PDF ↗ |
| K123897 | K SERIES CPAP SYSTEMS | Curative Medical, Inc. | 2013-03-13 | Special | PDF ↗ |
| K122847 | KANGAROO NASAL MASK | Respironics, Inc. | 2013-03-06 | Special | PDF ↗ |
| K123979 | QUATTRO AIR | Resmed, Ltd. | 2013-02-27 | Traditional | PDF ↗ |
| K121374 | ZI BLOWER | Deshum Medical | 2013-02-22 | Traditional | PDF ↗ |
| K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 | Apex Medical Corp. | 2012-12-06 | Traditional | PDF ↗ |
| K121321 | HARD SHELL VENTED NASAL MASK | Sleepnet Corporation | 2012-11-30 | Traditional | PDF ↗ |
| K121692 | MINIME 2 NASAL MASK | Sleepnet Corporation | 2012-11-05 | Traditional | PDF ↗ |
| K122350 | TAP PAP NASAL PILLOW MASK | Airway Management, Inc. | 2012-11-01 | Traditional | PDF ↗ |
| K121705 | GEO | Resmed, Ltd. | 2012-10-23 | Special | PDF ↗ |
| K122769 | REMSTAR SE | Respironics, Inc. | 2012-10-09 | Special | PDF ↗ |
| K121631 | SIMPLE T NASAL MASK | Respironics, Inc. | 2012-10-05 | Special | PDF ↗ |
| K121597 | ESON NASAL MASK | Fisher & Paykel Healthcare Limited | 2012-10-02 | Traditional | PDF ↗ |
| K120463 | MOJO, VERASEAL | Sleepnet Corporation | 2012-07-27 | Traditional | PDF ↗ |
| K120562 | PERFORMAX PEDIATRIC EE TOTAL FACE MASK | Respironics, Inc. | 2012-07-17 | Traditional | PDF ↗ |
| K120920 | HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA | Hsiner Company | 2012-07-16 | Traditional | PDF ↗ |
| K120285 | K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER | Curative Medical, Inc. | 2012-07-02 | Traditional | PDF ↗ |
| K113801 | VPAP ADAPT | Resmed Corp | 2012-05-25 | Traditional | PDF ↗ |
| K120035 | APEX MEDICAL ICH CPAP SERIES (9S-007XXX) | Apex Medical Corp. | 2012-05-16 | Special | PDF ↗ |
| K110629 | RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER | 3B Products, Inc. | 2012-04-27 | Traditional | PDF ↗ |
| K120757 | SLEEPWEAVER ELAN NASAL CPAP MASK | Circadiance, LLC | 2012-04-24 | Special | PDF ↗ |
| K113780 | EASYCARE TX SYSTEM (CONNEXUNS) | Resmed, Ltd. | 2012-04-20 | Traditional | PDF ↗ |
| K120145 | SIMPLE T NASAL MASK | Respironics, Inc. | 2012-03-30 | Special | PDF ↗ |
| K120027 | PILAIRO NASAL PILLOWS MASK | Fisher & Paykel Healthcare Limited | 2012-02-23 | Traditional | PDF ↗ |
| K112271 | 3B WILLOW | 3B Products, LLC | 2012-02-16 | Traditional | PDF ↗ |
| K113127 | MIRAGE QUATTRO | Resmed, Ltd. | 2012-01-06 | Special | PDF ↗ |
| K113068 | REMSTAR AUTO A-FLEX HT | Respironics, Inc. | 2011-12-16 | Special | PDF ↗ |
| K112489 | SWIFT FX BELLA | Resmed, Ltd. | 2011-12-07 | Special | PDF ↗ |
| K112220 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL | Devilbiss Healthcare, LLC | 2011-11-22 | Traditional | PDF ↗ |
| K112167 | SOYALA SILKGEL FULL FACE MASK | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-11-16 | Special | PDF ↗ |
| K112393 | TASMAN | Resmed, Ltd. | 2011-11-16 | Traditional | PDF ↗ |
| K103434 | 3B FLEX-LITE | 3B Products, LLC | 2011-10-13 | Traditional | PDF ↗ |
| K110471 | BABI PLUS INFANT NASAL CANNULA SYSTEM | A Plus Medical | 2011-10-07 | Special | PDF ↗ |
| K110316 | INFOSEND GSM | Fisher & Paykel Healthcare, Ltd. | 2011-08-19 | Traditional | PDF ↗ |
| K110383 | BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 | A Plus Medical | 2011-08-01 | Traditional | PDF ↗ |
| K110884 | EASYFIT SILKGEL NASAL MASK | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-07-12 | Special | PDF ↗ |
| K111148 | S8 ASPEN WITH H4I PLUS | Resmed Corp | 2011-06-30 | Special | PDF ↗ |
| K102625 | VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 | Vega Technologies, Inc. | 2011-06-10 | Traditional | PDF ↗ |
| K110405 | TRUBLUE NASAL MASK | Respironics, Inc. | 2011-06-06 | Special | PDF ↗ |
| K102317 | IQ VENTILATION NASAL MASK | Sleepnet Corporation | 2011-05-17 | Traditional | PDF ↗ |
| K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK | Apex Medical Corp. | 2011-05-06 | Traditional | PDF ↗ |
| K103410 | NEOPAP SYSTEM | Childrens Medical Ventures, LLC | 2011-03-30 | Traditional | PDF ↗ |
| K103395 | PERFORMAX TOTAL FACE MASK | Respironics, Inc. | 2011-03-24 | Special | PDF ↗ |
| K103786 | ZEST PETITE NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2011-03-24 | Traditional | PDF ↗ |
| K102586 | S9 VPAP ADAPT WITH H5I | Resmed, Ltd. | 2011-03-18 | Traditional | PDF ↗ |
| K110444 | MIRAGE MICRO | Resmed, Ltd. | 2011-03-16 | Special | PDF ↗ |
| K102515 | NP15 | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011-03-11 | Traditional | PDF ↗ |
| K110008 | GOLIFE NASAL MASK | Respironics, Inc. | 2011-02-17 | Special | PDF ↗ |
| K102513 | S9 VPAP ST WITH H5I | Resmed, Ltd. | 2011-01-05 | Traditional | PDF ↗ |
| K102746 | MIRAGE FX | Resmed, Ltd. | 2010-12-28 | Traditional | PDF ↗ |
| K102502 | GOLIFE NASAL MASK | Respironics, Inc. | 2010-12-22 | Special | PDF ↗ |
| K102224 | PIXI PEDIATRIC MASK | Resmed, Ltd. | 2010-12-10 | Traditional | PDF ↗ |
| K100011 | FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM | Fisher & Paykel Healthcare, Ltd. | 2010-10-08 | Traditional | PDF ↗ |
| K100121 | MODEL 300157 CPAP SYSTEM | Aeiomed, Inc. | 2010-07-13 | Abbreviated | PDF ↗ |
| K100772 | MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) | Resmed, Ltd. | 2010-06-09 | Special | PDF ↗ |
| K093716 | BABI PLUS INFANT NASAL CANNULA SYSTEM | A Plus Medical | 2010-05-13 | Traditional | PDF ↗ |
| K094040 | F&P ICON SERIES CPAP | Fisher & Paykel Healthcare, Ltd. | 2010-04-27 | Traditional | PDF ↗ |
| K100343 | PAP-CAP | Pur-Sleep, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K093124 | PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 | Cardinal Health 207, Inc. | 2010-03-10 | Special | PDF ↗ |
| K093684 | EASYCARE ONLINE | Resmed, Ltd. | 2010-02-26 | Traditional | PDF ↗ |
| K092835 | COMFORTGEL NASAL MASK | Respironics Inc., Sleep & Home Respiratory Group | 2010-02-12 | Traditional | PDF ↗ |
| K090804 | NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD | Innomed Technologies, Inc./Respcare, Inc. | 2009-11-05 | Traditional | PDF ↗ |
| K092362 | SLEEPWEAVER NASAL CPAP MASK | Circadiance, LLC | 2009-11-02 | Traditional | PDF ↗ |
| K092026 | EASYCARE TX, TX LINK | Resmed, Ltd. | 2009-10-02 | Traditional | PDF ↗ |
| K091919 | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST | Sunrise Medical | 2009-09-28 | Traditional | PDF ↗ |
| K091947 | S8 ASPEN WITH H4I PLUS | Resmed, Ltd. | 2009-09-28 | Traditional | PDF ↗ |
| K091843 | COMFORT TWIN NASAL MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-10 | Traditional | PDF ↗ |
| K091066 | COMFORT TWIN NASAL MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-09-03 | Traditional | PDF ↗ |
| K091129 | QUATTRO LT | Resmed, Ltd. | 2009-08-03 | Traditional | PDF ↗ |
| K091319 | REMSTAR AUTO A-FLEX | Respironics Inc., Sleep & Home Respiratory Group | 2009-08-03 | Traditional | PDF ↗ |
| K090935 | MINIME PEDIATRIC MASK | Sleepnet Corporation | 2009-07-01 | Traditional | PDF ↗ |
| K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-05-29 | Special | PDF ↗ |
| K091112 | RESPIRONICS SLEEPEASY CPAP SYSTEM | Respironics, Inc. | 2009-05-15 | Special | PDF ↗ |
| K090243 | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM | Respironics Inc., Sleep & Home Respiratory Group | 2009-05-08 | Special | PDF ↗ |
| K090490 | MIRAGE ECHO | Resmed Corp | 2009-05-06 | Traditional | PDF ↗ |
| K083656 | APEX MEDICAL XT AUTO CPAP 9S-005200 | Apex Medical Corp. | 2009-04-22 | Traditional | PDF ↗ |
| K090244 | SWIFT FX | Resmed, Ltd. | 2009-04-13 | Traditional | PDF ↗ |
| K082558 | COMFORTLITE NASAL MASK | Respironics, Inc. | 2009-03-25 | Traditional | PDF ↗ |
| K083816 | RES TRAXX ONLINE, MODEL: R14 | Resmed, Ltd. | 2009-03-20 | Traditional | PDF ↗ |
| K083832 | ZEST NASAL MASK | Fisher & Paykel Healthcare, Ltd. | 2009-03-16 | Traditional | PDF ↗ |
| K082866 | REVOLUTIONFULL FACE MASK | Respironics Inc., Sleep & Home Respiratory Group | 2009-01-30 | Traditional | PDF ↗ |
| K082605 | VPAP AUTO WITH HUMIDAIRE 3I | Resmed, Ltd. | 2009-01-13 | Traditional | PDF ↗ |
Product code BZD · Class II · Anesthesiology. Data: openFDA.