Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- BRWProtector, Dental1Product Code
- BSFAbsorber, Carbon-Dioxide1Product Code
- BSJMask, Gas, Anesthetic1Product Code
- BSKCuff, Tracheal Tube, Inflatable2Product Code
- BSNFilter, Conduction, Anesthetic2Product Code
- BSOCatheter, Conduction, Anesthetic2Product Code
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2Product Code
- BSRStylet, Tracheal Tube1Product Code
- BSZGas-Machine, Anesthesia2Product Code
- BTBHook, Ether1Product Code
- BTCBag, Reservoir1Product Code
- BTKStrap, Head, Gas Mask1Product Code
- BTLVentilator, Emergency, Powered (Resuscitator)2Product Code
- BTMVentilator, Emergency, Manual (Resuscitator)2Product Code
- BTOTube, Tracheostomy (W/Wo Connector)2Product Code
- BTPDropper, Ether1Product Code
- BTQAirway, Nasopharyngeal1Product Code
- BTRTube, Tracheal (W/Wo Connector)2Product Code
- BTSTube, Bronchial (W/Wo Connector)2Product Code
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2Product Code
- BWBForceps, Tube Introduction1Product Code
- BWCNeedle, Emergency Airway2Product Code
- BWFSpirometer, Therapeutic (Incentive)2Product Code
- BWLApparatus, Electronanesthesia3Product Code
- BYDCondenser, Heat And Moisture (Artificial Nose)1Product Code
- BYEAttachment, Breathing, Positive End Expiratory Pressure2Product Code
- BYFMask, Oxygen, Low Concentration, Venturi1Product Code
- BYGMask, Oxygen1Product Code
- BYHDrain, Tee (Water Trap)1Product Code
- BYIPercussor, Powered-Electric2Product Code
- BYJUnit, Liquid-Oxygen, Portable2Product Code
- BYKTent, Oxygen, Electrically Powered2Product Code
- BYLTent, Oxygen1Product Code
- BYNChair, Posture, For Cardiac And Pulmonary Treatment1Product Code
- BYOBottle, Blow1Product Code
- BYPMouthpiece, Breathing1Product Code
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)2Product Code
- BYWDevice, Rebreathing1Product Code
- BYXTubing, Pressure And Accessories1Product Code
- BZAConnector, Airway (Extension)1Product Code
- BZBCatheter, Nasal, Oxygen1Product Code
- BZDVentilator, Non-Continuous (Respirator)2Product Code
- K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask2Cleared 510(K)
- K233415DELTAWAVE Nasal Pillows System2Cleared 510(K)
- K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask2Cleared 510(K)
- K230476Oran Park Mask2Cleared 510(K)
- K231313Therapy Mask 3100 NC/SP2Cleared 510(K)
- K223747Whitsundays Mask System2Cleared 510(K)
- K221436F&P 950 Accessory Breathing Circuit Kits2Cleared 510(K)
- K223696F&P Solo Mask Range2Cleared 510(K)
- K212263Luna G3 BPAP System2Cleared 510(K)
- K212371F&P Evora Full Face Mask2Cleared 510(K)
- K211155Auto CPAP System2Cleared 510(K)
- K211274iQ 2 Nasal Mask, Phantom 2 Nasal Mask2Cleared 510(K)
- K210844DreamWear Silicone Pillows Mask2Cleared 510(K)
- K210386Magneto Nasal Mask2Cleared 510(K)
- K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask2Cleared 510(K)
- K203601Innova Nasal Non-Vented Mask2Cleared 510(K)
- K201620Luna® G3 BPAP 25A2Cleared 510(K)
- K200565Galapogos2Cleared 510(K)
- K203126S10 Kirra2Cleared 510(K)
- K192177SysMed S/T2Cleared 510(K)
- K193206WiZARD 510 Nasal Mask2Cleared 510(K)
- K201439Ventilator, Non-continuous (Respirator)2Cleared 510(K)
- K200480DreamStation 2 System, DreamStation 2 Advanced System2Cleared 510(K)
- K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model2Cleared 510(K)
- K183226Care Orchestrator Essence2Cleared 510(K)
- K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)2Cleared 510(K)
- K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask2Cleared 510(K)
- K182394WiZARD 310/320 Series CPAP Mask2Cleared 510(K)
- K183512Moore Park Mask2Cleared 510(K)
- K181053Care Orchestrator2Cleared 510(K)
- K180388Transcend 365 miniCPAP System2Cleared 510(K)
- K173193F&P SleepStyle2Cleared 510(K)
- K180497Scone Mask2Cleared 510(K)
- K172335Bleep DreamPort2Cleared 510(K)
- K170924AirFit F202Cleared 510(K)
- K171212AirFit N202Cleared 510(K)
- K163464Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)2Cleared 510(K)
- K162905SleepWeaver 3D Nasal Mask2Cleared 510(K)
- K161686F&P InfoSmart2Cleared 510(K)
- K161412F&P Brevida™ Nasal Pillows Mask2Cleared 510(K)
- K160836Menai System2Cleared 510(K)
- K161978AirFit N202Cleared 510(K)
- K160127iCodeConnect2Cleared 510(K)
- K153505F&P Eson 2 Nasal Mask2Cleared 510(K)
- K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV2Cleared 510(K)
- K153387Luna CPAP and Auto CPAP System2Cleared 510(K)
- K153563AirFit F202Cleared 510(K)
- K153673AirFit N202Cleared 510(K)
- K151120Simple T Pediatric Nasal Mask2Cleared 510(K)
- K151683SleepWeaver Advance Pediatric Nasal CPAP Mask2Cleared 510(K)
- K152810DeVilbiss DV6WM Wireless Modem2Cleared 510(K)
- K152356Sapphire2Cleared 510(K)
- K150639AF541 EE Full Face Mask2Cleared 510(K)
- K143677DeVilbiss Intellipap2/DeVilbiss BLUE2Cleared 510(K)
- K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series2Cleared 510(K)
- K150685Skynector CPAP Mask2Cleared 510(K)
- K143700CPAP Cannulaide2Cleared 510(K)
- K150365Cloud9 System2Cleared 510(K)
- K143603Darlinghurst Vented, Darlinghurst NV-AAV2Cleared 510(K)
- K141770LUNA CPAP AND AUTO-CPAP SYSTEM2Cleared 510(K)
- K140980TI NASAL MASK2Cleared 510(K)
- K140580REVOLUTION FULLFACE MASK2Cleared 510(K)
- K142554Revolution Full Face Mask2Cleared 510(K)
- K140268SIMPLE T YOUTH NASAL MASK2Cleared 510(K)
- K141152ADVANTAGE2Cleared 510(K)
- K140929Z1 CPAP SYSTEM2Cleared 510(K)
- K141522APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES2Cleared 510(K)
- K1337693B RESMART BPAP 25A, BMC RESMART BPAP 25A2Cleared 510(K)
- K140880DEVILBISS SMARTLINK II SYSTEM2Cleared 510(K)
- K140279S9 GREENHILLS2Cleared 510(K)
- K140159S9 WANDA VPAP ST2Cleared 510(K)
- K132901AIRSOFT F152Cleared 510(K)
- K140054RESCAN2Cleared 510(K)
- K140124S9 ELOUERA2Cleared 510(K)
- K133009NASAL MASK, NASAL MASK, FULL FACE MASK2Cleared 510(K)
- K132606S9 CRONULLA FOR HER2Cleared 510(K)
- K130828K SERIES CPAP SYSTEMS2Cleared 510(K)
- K131901IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N22Cleared 510(K)
- K132887AIRFIT N102Cleared 510(K)
- K1329673B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP2Cleared 510(K)
- K131702K SERIES CPAP SYSTEMS2Cleared 510(K)
- K132168BRONCHOSCOPY ELBOW2Cleared 510(K)
- K132013SWIFT AIR2Cleared 510(K)
- K131982REMSTAR AUTO A-FLEX HT2Cleared 510(K)
- K132127TRANSCEND AUTO2Cleared 510(K)
- K130686NASAL COMFORT FREEDOM2Cleared 510(K)
- K131502SEATTLE - PAP2Cleared 510(K)
- K130663BESTFIT2 NASAL MASK2Cleared 510(K)
- K1317073B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS2Cleared 510(K)
- K121642WIZARD 230 NASAL PILOW MASK2Cleared 510(K)
- K130328F&P SIMPLUS FULL FACE MASK2Cleared 510(K)
- K130481SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK2Cleared 510(K)
- K130077REMSTAR SE2Cleared 510(K)
- K130037BREATHE CPAP SYSTEM2Cleared 510(K)
- K123789SWIFT FX NANO2Cleared 510(K)
- K121747FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS2Cleared 510(K)
- K123897K SERIES CPAP SYSTEMS2Cleared 510(K)
- K122847KANGAROO NASAL MASK2Cleared 510(K)
- K123979QUATTRO AIR2Cleared 510(K)
- K121374ZI BLOWER2Cleared 510(K)
- K112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-0057202Cleared 510(K)
- K121321HARD SHELL VENTED NASAL MASK2Cleared 510(K)
- K121692MINIME 2 NASAL MASK2Cleared 510(K)
- K122350TAP PAP NASAL PILLOW MASK2Cleared 510(K)
- K121705GEO2Cleared 510(K)
- K122769REMSTAR SE2Cleared 510(K)
- K121631SIMPLE T NASAL MASK2Cleared 510(K)
- K121597ESON NASAL MASK2Cleared 510(K)
- K120463MOJO, VERASEAL2Cleared 510(K)
- K120562PERFORMAX PEDIATRIC EE TOTAL FACE MASK2Cleared 510(K)
- K120920HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA2Cleared 510(K)
- K120285K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER2Cleared 510(K)
- K113801VPAP ADAPT2Cleared 510(K)
- K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)2Cleared 510(K)
- K110629RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER2Cleared 510(K)
- K120757SLEEPWEAVER ELAN NASAL CPAP MASK2Cleared 510(K)
- K113780EASYCARE TX SYSTEM (CONNEXUNS)2Cleared 510(K)
- K120145SIMPLE T NASAL MASK2Cleared 510(K)
- K120027PILAIRO NASAL PILLOWS MASK2Cleared 510(K)
- K1122713B WILLOW2Cleared 510(K)
- K113127MIRAGE QUATTRO2Cleared 510(K)
- K113068REMSTAR AUTO A-FLEX HT2Cleared 510(K)
- K112489SWIFT FX BELLA2Cleared 510(K)
- K112220DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL2Cleared 510(K)
- K112393TASMAN2Cleared 510(K)
- K112167SOYALA SILKGEL FULL FACE MASK2Cleared 510(K)
- K1034343B FLEX-LITE2Cleared 510(K)
- K110471BABI PLUS INFANT NASAL CANNULA SYSTEM2Cleared 510(K)
- K110316INFOSEND GSM2Cleared 510(K)
- K110383BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H202Cleared 510(K)
- K110884EASYFIT SILKGEL NASAL MASK2Cleared 510(K)
- K111148S8 ASPEN WITH H4I PLUS2Cleared 510(K)
- K102625VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-032Cleared 510(K)
- K110405TRUBLUE NASAL MASK2Cleared 510(K)
- K102317IQ VENTILATION NASAL MASK2Cleared 510(K)
- K103174APEX MEDICAL WIZARD SERIES CPAP MASK2Cleared 510(K)
- K103410NEOPAP SYSTEM2Cleared 510(K)
- K103786ZEST PETITE NASAL MASK2Cleared 510(K)
- K103395PERFORMAX TOTAL FACE MASK2Cleared 510(K)
- K102586S9 VPAP ADAPT WITH H5I2Cleared 510(K)
- K110444MIRAGE MICRO2Cleared 510(K)
- K102515NP152Cleared 510(K)
- K110008GOLIFE NASAL MASK2Cleared 510(K)
- K102513S9 VPAP ST WITH H5I2Cleared 510(K)
- K102746MIRAGE FX2Cleared 510(K)
- K102502GOLIFE NASAL MASK2Cleared 510(K)
- K102224PIXI PEDIATRIC MASK2Cleared 510(K)
- K100011FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM2Cleared 510(K)
- K100121MODEL 300157 CPAP SYSTEM2Cleared 510(K)
- K100772MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)2Cleared 510(K)
- K093716BABI PLUS INFANT NASAL CANNULA SYSTEM2Cleared 510(K)
- K094040F&P ICON SERIES CPAP2Cleared 510(K)
- K100343PAP-CAP2Cleared 510(K)
- K093124PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-032Cleared 510(K)
- K093684EASYCARE ONLINE2Cleared 510(K)
- K092835COMFORTGEL NASAL MASK2Cleared 510(K)
- K090804NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD2Cleared 510(K)
- K092362SLEEPWEAVER NASAL CPAP MASK2Cleared 510(K)
- K092026EASYCARE TX, TX LINK2Cleared 510(K)
- K091947S8 ASPEN WITH H4I PLUS2Cleared 510(K)
- K091919DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST2Cleared 510(K)
- K091843COMFORT TWIN NASAL MASK2Cleared 510(K)
- K091066COMFORT TWIN NASAL MASK2Cleared 510(K)
- K091319REMSTAR AUTO A-FLEX2Cleared 510(K)
- K091129QUATTRO LT2Cleared 510(K)
- K090935MINIME PEDIATRIC MASK2Cleared 510(K)
- K091271RESPIRONICS PERFORMAX TOTAL FACE MASK2Cleared 510(K)
- K091112RESPIRONICS SLEEPEASY CPAP SYSTEM2Cleared 510(K)
- K090243REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM2Cleared 510(K)
- K090490MIRAGE ECHO2Cleared 510(K)
- K083656APEX MEDICAL XT AUTO CPAP 9S-0052002Cleared 510(K)
- K090244SWIFT FX2Cleared 510(K)
- K082558COMFORTLITE NASAL MASK2Cleared 510(K)
- K083816RES TRAXX ONLINE, MODEL: R142Cleared 510(K)
- K083832ZEST NASAL MASK2Cleared 510(K)
- K082866REVOLUTIONFULL FACE MASK2Cleared 510(K)
- K082605VPAP AUTO WITH HUMIDAIRE 3I2Cleared 510(K)
- K082979S8 ADVANCE2Cleared 510(K)
- K082983RESSCAN-PRO2Cleared 510(K)
- K082209DEVILBISS DV5M SMARTLINK SYSTEM2Cleared 510(K)
- K082237PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST2Cleared 510(K)
- K081321MODIFICATION TO MIRAGE MICRO2Cleared 510(K)
- K081029SLEEPSTYLE 200 AUTO SERIES HC2542Cleared 510(K)
- K080209FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK2Cleared 510(K)
- K080516LAMIN AIR2Cleared 510(K)
- K080439SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE2Cleared 510(K)
- K071915CPAP MASK2Cleared 510(K)
- K081014SOYALA GEL VENTED2Cleared 510(K)
- K073600COMFORTGEL FULL FACE MASK2Cleared 510(K)
- K080079S8 ESCAPE II2Cleared 510(K)
- K080131VPAP ST2Cleared 510(K)
- K073673SOYALA FULL FACE MASK GEL VENTED2Cleared 510(K)
- K073638SWIFT LT2Cleared 510(K)
- K072993REUSABLE HEADREST WITH NASAL SEAL2Cleared 510(K)
- K071149HRI 6500, 6600 AND 6700 SERIES V2MASKS2Cleared 510(K)
- K072615TXCONTROL2Cleared 510(K)
- K072996REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM2Cleared 510(K)
- K072592PERFORMAX TOTAL FACE MASK2Cleared 510(K)
- K072009WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 273402Cleared 510(K)
- K072940MIRAGE MICRO2Cleared 510(K)
- K072755GALEMED CPAP MASK2Cleared 510(K)
- K071808MIRAGE MICRO2Cleared 510(K)
- K071773CPAP NASAL MASK WITH PILLOWS2Cleared 510(K)
- K071575SANDMAN INTRO2Cleared 510(K)
- K071689DEVILBISS INTELLIPAP MODEL DV 5 SERIES2Cleared 510(K)
- K071163WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 276032Cleared 510(K)
- K070746RESTRAXX DATA CENTRE, MODEL R102Cleared 510(K)
- K071171VPAP AUTO WITH H3I2Cleared 510(K)
- K071069MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY2Cleared 510(K)
- K070609APEX MEDICAL XT1 CPAP, MODEL 9S-0052Cleared 510(K)
- K070321TWILIGHT FULL FACE MASK2Cleared 510(K)
- K063501KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US2Cleared 510(K)
- K063830REMSTAR AFLEX CPAP SYSTEM2Cleared 510(K)
- K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 12352Cleared 510(K)
- K063122MIRAGE QUATTRO FULL FACE MASK2Cleared 510(K)
- K063011MIRAGE LIBERTY FULL FACE MASK2Cleared 510(K)
- K063476BREAS ISLEEP 20I2Cleared 510(K)
- K063036OPUS HC482 DIRECT NASAL MASK2Cleared 510(K)
- K061653SOYALA FULL FACE MASK2Cleared 510(K)
- K062291VPAP MALIBU WITH H2I2Cleared 510(K)
- K061874INVACARE'S TWILIGHT II NASAL MASKS2Cleared 510(K)
- K061236FLEXIFIT HC432 FULL FACE MASK2Cleared 510(K)
- K060657ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.2Cleared 510(K)
- K062224RESPCARE HYBRID AV MASK2Cleared 510(K)
- K061099BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-00032Cleared 510(K)
- K061200PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER2Cleared 510(K)
- K060067MASKMEDIC CONCEPT NASAL MASK2Cleared 510(K)
- K061057BREAS ISLEEP 20+2Cleared 510(K)
- K061034BIPAP PLUS M-SERIES BI-LEVEL SYSTEM2Cleared 510(K)
- K060405SOYALA, SOYALA BLUE2Cleared 510(K)
- K060273SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 538372Cleared 510(K)
- K053352COMFORTLITE NASAL MASK2Cleared 510(K)
- K053205RES TRAXX DATA CENTER2Cleared 510(K)
- K053486TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET2Cleared 510(K)
- K052597BREATHEX OMEGA CPAP DEVICE, MODEL 3222Cleared 510(K)
- K052249UTOPIA2Cleared 510(K)
- K051226AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER2Cleared 510(K)
- K051583TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-30502Cleared 510(K)
- K052227RESPCARE FACE MASK2Cleared 510(K)
- K052110M-SERIES PRO CPAP SYTEM2Cleared 510(K)
- K050994AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM2Cleared 510(K)
- K051314RES TRAXX DATA CENTER2Cleared 510(K)
- K051559IMASK, MODELS 100, 200 AND 3002Cleared 510(K)
- K050759BIPAP AUTO2Cleared 510(K)
- K050072GOODKNIGHT 425ST2Cleared 510(K)
- K050904CPAP HUMIDIFIER, MODEL HC238JHU2Cleared 510(K)
- K050775RESSCAN2Cleared 510(K)
- K041823PIONEER U121 SERIES CPAP2Cleared 510(K)
- K050171IT NASAL MASK2Cleared 510(K)
- K050359ULTRA MIRAGE II MASK2Cleared 510(K)
- K042945AURA CPAP SYSTEM2Cleared 510(K)
- K040202SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM2Cleared 510(K)
- K050142RESMED MERIDIAN MASK2Cleared 510(K)
- K043282DEVILBISS AUTOADJUST, MODEL 9054 SERIES2Cleared 510(K)
- K043607BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX2Cleared 510(K)
- K043382TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-28402Cleared 510(K)
- K042455DEVILBISS NASAL CPAP MASK, 9354 SERIES2Cleared 510(K)
- K042403MIRAGE SWIFT2Cleared 510(K)
- K042294SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)2Cleared 510(K)
- K042130AURA CPAP PATIENT INTERFACE2Cleared 510(K)
- K041900HC604 CPAP HUMIDIFIER2Cleared 510(K)
- K041828APEX MEDICAL CPAP MODEL 9S-0032Cleared 510(K)
- K041819GOODKNIGHT 425, MODELM-114500-002Cleared 510(K)
- K041362RESMED HOSPITAL FULL FACE MASK2Cleared 510(K)
- K041209RESMED S8 PIONEER CPAP SYSTEM2Cleared 510(K)
- K041309IMASK TM2Cleared 510(K)
- K040862GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM2Cleared 510(K)
- K034053TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-30402Cleared 510(K)
- K040941CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)2Cleared 510(K)
- K041035HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND2Cleared 510(K)
- K040944RESCONTROL II2Cleared 510(K)
- K040726VENTLAB NASAL CPAP CANNULA2Cleared 510(K)
- K041010REMSTAR AUTO WITH C-FLEX CPAP SYSTEM2Cleared 510(K)
- K040506FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A2Cleared 510(K)
- K034033RESCAN2Cleared 510(K)
- K033914OXYGEN DIVERTER VALVE2Cleared 510(K)
- K040566RESMED HOSPITAL NASAL MASK2Cleared 510(K)
- K031064INVACARE POLARIS EX CPAP, MODEL ISP30002Cleared 510(K)
- K033841RESMED S8 PRIME CPAP SYSTEM2Cleared 510(K)
- K030797S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM2Cleared 510(K)
- K032834BIPAP PRO 2 BI-LEVEL SYSTEM2Cleared 510(K)
- K031935TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-25302Cleared 510(K)
- K032056BILEVEL CPAP, MODEL 9055 SERIES2Cleared 510(K)
- K033759C2 NASAL MASK2Cleared 510(K)
- K031745INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION2Cleared 510(K)
- K022650APEX MEDICAL CPAP RT 21XX2Cleared 510(K)
- K033087ORACLE ORAL MASK, MODEL HC451A2Cleared 510(K)
- K032916MIRAGE ACTIVA MASK2Cleared 510(K)
- K023683MULTI-STRAP FULL FACE MASK2Cleared 510(K)
- K032433NASAL JACKS MASK2Cleared 510(K)
- K032480AUTOSET SPIRIT SYSTEM2Cleared 510(K)
- K030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10I2Cleared 510(K)
- K030563ARABELLA NCPAP MASKS2Cleared 510(K)
- K031883LYRA NASAL MASK2Cleared 510(K)
- K031047MIRAGE VISTA MASK2Cleared 510(K)
- K030843VPAP III2Cleared 510(K)
- K014074HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION2Cleared 510(K)
- K024191S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK2Cleared 510(K)
- K031460MODIFICATION TO REMSTAR AUTO CPAP SYSTEM2Cleared 510(K)
- K023670SINGLE USE ORAL MASK, MODEL HC455A2Cleared 510(K)
- K023559FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK2Cleared 510(K)
- K031470PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US2Cleared 510(K)
- K0308227600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS2Cleared 510(K)
- K023068PAPILLON MASK SET2Cleared 510(K)
- K030798MIRAGE ACTIVA MASK2Cleared 510(K)
- K022465MODIFICATION TO NASAL-AIRE2Cleared 510(K)
- K022642TWLIGHT, MODEL ISP 96002Cleared 510(K)
- K022192PEGASUS NASAL CPAP SYSTEM2Cleared 510(K)
- K023306MIRAGE FULL FACE MASK SERIES 22Cleared 510(K)
- K023284MIRAGE FULL FACE MASK SERIES 22Cleared 510(K)
- K023244MIRAGE FULL FACE MASK SERIES 22Cleared 510(K)
- K022934SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 236502Cleared 510(K)
- K020886PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US2Cleared 510(K)
- K020641SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 0012Cleared 510(K)
- K0207597600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT2Cleared 510(K)
- K013843AUTOSET SPIRIT CPAP SYSTEM2Cleared 510(K)
- K013909S7 ELITE CP AP SYSTEM2Cleared 510(K)
- K021534IQ NASAL MASK, MODEL 50160 REV. D2Cleared 510(K)
- K021861REMSTAR PRO WITH C-FLEX CPAP SYSTEM2Cleared 510(K)
- K020730ORION NASAL CPAP SYSTEM2Cleared 510(K)
- K012554REMSTAR AUTO CPAP SYSTEM2Cleared 510(K)
- K013738WEINMANN SOMNOMASK2Cleared 510(K)
- K013421LIFEGUARD NASAL CPAP MASK AND ACCESSORIES2Cleared 510(K)
- K013306MINIME NASAL MASK, MODEL P/N 502202Cleared 510(K)
- K012034MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT2Cleared 510(K)
- K012207ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 25302Cleared 510(K)
- K011229DEVILBISS 9000 SERIES CPAP, MODEL 90012Cleared 510(K)
- K011714BIPAP PRO BI-LEVEL SYSTEM2Cleared 510(K)
- K003894ORACLE ORAL MASK2Cleared 510(K)
- K011516INFANT FLOW SYSTEM, MODEL M672P2Cleared 510(K)
- K002763REMREST2Cleared 510(K)
- K010704DORNIR LC-1 CPAP SYSTEM2Cleared 510(K)
- K010263REMSTAR PLUS CPAP SYSTEM2Cleared 510(K)
- K993094AERO-CLICK2Cleared 510(K)
- K002465SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 10048762Cleared 510(K)
- K000705RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 10032232Cleared 510(K)
- K002001BREEZE SLEEPGEAR WITH DREAMSEAL2Cleared 510(K)
- K000888SANSIBAR CPAP SYSTEM2Cleared 510(K)
- K001553BREAS PV 100 CPAP SYSTEM2Cleared 510(K)
- K001845MALLINCKRODT, GOODKNIGHT 418S2Cleared 510(K)
- K000994BIPAP DUET LX BI-LEVEL SYSTEM2Cleared 510(K)
- K000215SWIVEL ELBOW2Cleared 510(K)
- K992192AIRPILOTMASK, MODEL TMS-9002Cleared 510(K)
- K993584MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 22Cleared 510(K)
- K990856HERITAGE NASAL CPAP SYSTEM, MODEL P/N 156822Cleared 510(K)
- K992384CPAP/PRO CPAP INTERFACE2Cleared 510(K)
- K990659NASAL AIRE2Cleared 510(K)
- K992969RESPIRONICS TOTAL FACE MASK2Cleared 510(K)
- K993433VIRTUOSO LX SMART CPAP SYSTEM2Cleared 510(K)
- K993307ARIA LX CPAP SYSTEM2Cleared 510(K)
- K993269IQ NASAL MASK, MODEL P/N 501602Cleared 510(K)
- K991926OPAP2Cleared 510(K)
- K992336MONARCH II MINI MASK2Cleared 510(K)
- K991972INFANT FLOW SYSTEM2Cleared 510(K)
- K984428SULLIVAN AUTOSET NASAL CPAP SYSTEM2Cleared 510(K)
- K991648REUSABLE CONTOUR II NASAL MASK2Cleared 510(K)
- K991150NELLCOR PURITAN BENNETT, GOODKNIGHT 418G2Cleared 510(K)
- K984254INFANT FLOW NCPAP MASKS2Cleared 510(K)
- K982242INVACARE CPAP2Cleared 510(K)
- K980551SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM2Cleared 510(K)
- K982530SULLIVAN MIRAGE FULL FACE MASK2Cleared 510(K)
- K981744COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER2Cleared 510(K)
- K980721SULLIVAN AUTOSET2Cleared 510(K)
- K974453NASAL INTERFACE MODEL 79102Cleared 510(K)
- K980365GOODKNIGHT 418 CPAP SYSTEM2Cleared 510(K)
- K973161CPAP HUMIDIFIER (HC 200)2Cleared 510(K)
- K974879MODEL 7410 VOYAGER2Cleared 510(K)
- K974303INFANT FLOW SYSTEM2Cleared 510(K)
- K972605EMS NASAL CPAP MASK2Cleared 510(K)
- K964092TMS COMFORT SERIES NASAL CPAP MASK2Cleared 510(K)
- K970771SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM2Cleared 510(K)
- K964019MORPHEE PLUS ALPHA2Cleared 510(K)
- K970516SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM2Cleared 510(K)
- K963761QUARTET CLINICAL SYSTEM2Cleared 510(K)
- K970173MODEL 1700 TRANQUILITY BILEVEL SYSTEM2Cleared 510(K)
- K951944NASALFLAIR2Cleared 510(K)
- K964363BIPAP DUET SYSTEM2Cleared 510(K)
- K962203WHISPER SWIVEL II EXHALATION PORT2Cleared 510(K)
- K963250PRESSURE VALVE2Cleared 510(K)
- K962713DPAP STEALTH SLEEPNET MODEL NUMBER 840002Cleared 510(K)
- K953930VIRTUOSO SMART CPAP SYSTEM2Cleared 510(K)
- K961915SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE2Cleared 510(K)
- K961783SULLIVAN VPAP II ST NASAL VPAP SYSTEM2Cleared 510(K)
- K943207NITELIFE BI-LEVEL CPAP2Cleared 510(K)
- K961626SOLO CPAP SYSTEM2Cleared 510(K)
- K952429RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM2Cleared 510(K)
- K954572MAESTRO CLINICAL REMOTE CONTROL2Cleared 510(K)
- K953697THE IMS DPAP MASK, IMS MODEL NUMBER 820002Cleared 510(K)
- K952475SULLIVAN NOSE & MOUTH MASK SYSTEM2Cleared 510(K)
- K960518THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM2Cleared 510(K)
- K952966CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM2Cleared 510(K)
- K950849MODEL #73542Cleared 510(K)
- K954207GEL MASK2Cleared 510(K)
- K952491MODEL 73552Cleared 510(K)
- K945938RESPIRONICS MONARCH MINI MASK2Cleared 510(K)
- K953341ARIA CPAP SYSTEM2Cleared 510(K)
- K952292PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM2Cleared 510(K)
- K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)2Cleared 510(K)
- K936047SPECTRUM(TM) MASK2Cleared 510(K)
- K934804PURITAN-BENNETT COMPANION 320 I/E2Cleared 510(K)
- K933184POSITIVE AIRWAY PRESSURE SYSTEM2Cleared 510(K)
- K935979CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM2Cleared 510(K)
- K933947LIFECARE CPAP-2002Cleared 510(K)
- K9435097300 NASAL CPAP SYSTEM2Cleared 510(K)
- K935784PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM2Cleared 510(K)
- K931884SULLIVAN NASAL VPAP SYSTEM2Cleared 510(K)
- K930656SULLIVAN III NASAL CPAP SYSTEM2Cleared 510(K)
- K931484REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S2Cleared 510(K)
- K925587NASAL/ORAL MASK2Cleared 510(K)
- K925920TOTAL FACE MASK2Cleared 510(K)
- K923590318A RESPIRATORY SUPPORT SYSTEM2Cleared 510(K)
- K920699REMSTAR WTIH RAMP AND REMOTE MODIFICATION2Cleared 510(K)
- K911465INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL2Cleared 510(K)
- K912224LIFECARE CPAP-1002Cleared 510(K)
- K911856RESPIRONICS REMSTAR WITH REMOTE AND RAMP2Cleared 510(K)
- K912434SALTER LABS INFANT NASAL CPAP CANNULA2Cleared 510(K)
- K911780INFANT NASAL CANNULAE ASSEMBLY, MODIFIED2Cleared 510(K)
- K910194COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM2Cleared 510(K)
- K905404MEDTRONIC SULLIVAN NASAL CPAP SYSTEM2Cleared 510(K)
- K904344SLEEPER MASK SYSTEM2Cleared 510(K)
- K905593SLEEPAP2Cleared 510(K)
- K904766DEVILBISS MODEL 7352 SERIES2Cleared 510(K)
- K905540RESPIRONICS BIPAP REMOTE CONTROL UNIT2Cleared 510(K)
- K895031MODIFIED INFANT NASAL CANNULAE ASSEMBLY2Cleared 510(K)
- K871351H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP2Cleared 510(K)
- K871157C.P.A.P. NASAL CANNULA2Cleared 510(K)
- K864883NEONATAL CANNULA CAP2Cleared 510(K)
- K863746BIRD NIGHTBIRD NASAL CPAP SYSTEM2Cleared 510(K)
- K862448FLOW GENERATOR FOR SLEEP APNEA, LDS 15002Cleared 510(K)
- K861555CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT2Cleared 510(K)
- K861280MEDICOMP CPAP NASAL CANNULA2Cleared 510(K)
- K853487PATIENT BREATHING CIRCUIT2Cleared 510(K)
- K852821DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)2Cleared 510(K)
- K841773INFANT NASAL CANNULAE ASSEMBLY2Cleared 510(K)
- K823936CPAP INFANT NASAL CANNULAE SET2Cleared 510(K)
- K813075TRITEC DOC TM2Cleared 510(K)
- K811409ARGYLE CPAP NASAL CANNULA2Cleared 510(K)
- K792722NOVAMETRIX CPAP NASAL CANNULA2Cleared 510(K)
- K771217ANESTHESIA RESPIRATOR2Cleared 510(K)
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- BZRMixer, Breathing Gases, Anesthesia Inhalation2Product Code
- CADVaporizer, Anesthesia, Non-Heated2Product Code
- CAEAirway, Oropharyngeal, Anesthesiology1Product Code
- CAFNebulizer (Direct Patient Interface)2Product Code
- CAGCirculator, Breathing-Circuit2Product Code
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1Product Code
- CALLaryngoscope, Non-Rigid1Product Code
- CAOAirway, Esophageal (Obturator)2Product Code
- CATCannula, Nasal, Oxygen1Product Code
- CAWGenerator, Oxygen, Portable2Product Code
- CAZAnesthesia Conduction Kit2Product Code
- CBFChamber, Hyperbaric2Product Code
- CBGSpreader, Cuff1Product Code
- CBHDevice, Fixation, Tracheal Tube1Product Code
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2Product Code
- CBKVentilator, Continuous, Facility Use2Product Code
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- MODAccessory To Continuous Ventilator (Respirator)2Product Code
- CCOBed, Rocking, Breathing Assist2Product Code
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1Product Code
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia2Product Code
- CCWLaryngoscope, Rigid1Product Code
- EPEBrush, Cleaning, Tracheal Tube1Product Code
- FNCTent, Pediatric Aerosol2Product Code
- FOGHood, Oxygen, Infant1Product Code
- JAYSupport, Breathing Tube1Product Code
- JOHTube Tracheostomy And Tube Cuff2Product Code
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)1Product Code
- KGBMask, Oxygen, Non-Rebreathing1Product Code
- KHAMask, Scavenging1Product Code
- LNZChanger, Tube, Endotracheal2Product Code
- MIANeedle, Spinal, Short Term2Product Code
- MNSVentilator, Continuous, Non-Life-Supporting2Product Code
- MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use2Product Code
- MRNApparatus, Nitric Oxide Delivery2Product Code
- MROApparatus, Nitric Oxide, Backup Delivery2Product Code
- MZTDevice, Heimlich Maneuver Assist2Product Code
- NFBConserver, Oxygen2Product Code
- NHJDevice, Positive Pressure Breathing, Intermittent2Product Code
- NHKResuscitator, Manual, Non Self-Inflating2Product Code
- NMATube, Tracheal, Reprocessed2Product Code
- NMCMask, Ventilator, Non-Continuous, Reprocessed2Product Code
- NMRNeedle, Spinal, Short Term, Reprocessed2Product Code
- NNHNeedle, Conduction, Anesthesia, Reprocessed2Product Code
- NOUContinuous, Ventilator, Home Use2Product Code
- NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use2Product Code
- NVOSpacer, Direct Patient Interface2Product Code
- NVPHolding Chambers, Direct Patient Interface2Product Code
- NXATracheotomy Care Kit2Product Code
- OBNHumidifier, Respiratory, Mask (Direct Patient Interface)2Product Code
- OFQAnesthesia Kit2Product Code
- OFTSpinal Epidural Anesthesia Kit2Product Code
- OFUSpinal Anesthesia Kit2Product Code
- OFVRegional Anesthesia Kit2Product Code
- OGABrachial Plexus Anesthesia Kit2Product Code
- OGBCaudal Anesthesia Kit2Product Code
- OGCContinuous Brachial Plexus Block Tray2Product Code
- OGDCustom Anesthesia Tray2Product Code
- OGEEpidural Anesthesia Kit2Product Code
- OGFGlossopharyngeal Anesthesia Kit2Product Code
- OGGHumidifier Nebulizer Kit2Product Code
- OGHLaryngoscope Kit1Product Code
- OGINasal Endotracheal Tube Holder Kit1Product Code
- OGJNerve Block Tray2Product Code
- OGLOxygen Administration Kit2Product Code
- OLFMedevac Use Oxygen Generator2Product Code
- ONZMechanical Ventilator2Product Code
- OQUAirway Monitoring System2Product Code
- PHSOral Airway Assist1Product Code
- PMBExternal Airway2Product Code
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2Product Code
- QBYPositive Airway Pressure System2Product Code
- QCXRetrograde Intubation Set2Product Code
- OZRIntraoral Pressure Gradient Device2Product Code
- QFBIsocapnic Ventilation Device2Product Code
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AF541 EE Full Face Mask
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K150639
- 510(k) Type
- Abbreviated
- Applicant
- RESPIRONICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/18/2015
- Days to Decision
- 191 days
- Submission Type
- Summary