Anesthesiology

CAI · Circuit, Breathing (W Connector, Adaptor, Y Piece)

Anesthesiology · 21 CFR 868.5240 · Class 1

Overview

Product CodeCAI
Device NameCircuit, Breathing (W Connector, Adaptor, Y Piece)
Regulation21 CFR 868.5240
Device ClassClass 1
Review PanelAnesthesiology

Identification

An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Cleared Devices (184)

RecordDevice NameApplicantDecision DateDecision
K954480CONDENSATE COLLECTION KITNova-VentrxDec 29, 1995SESE
K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.Sep 19, 1995SESE
K953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.Sep 19, 1995SESE
K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.May 22, 1995SESE
K952019PRIMA ADULT GAS SAMPLING CIRCUITSPrima, Inc.May 22, 1995SESE
K952018PRIMA COAXIAL CIRCUITSPrima, Inc.May 22, 1995SESE
K952017PRIMA MAPLESON D CIRCUITPrima, Inc.May 22, 1995SESE
K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.May 22, 1995SESE
K952014PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSPrima, Inc.May 22, 1995SESE
K952009PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITSPrima, Inc.May 19, 1995SESE
K945565SPIRO-FLEXInhalation PlasticsJan 13, 1995SESE
K932288NEONATAL BREATHING CIRCUIT MODIFICATIONSimplex Medical Systems, Inc.Dec 30, 1994SESE
K945984MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITSMeridian Medical Systems, Inc.Dec 27, 1994SESE
K944533PRIMA, INC. ADULT ANESTHESIA CIRCUITPrima, Inc.Nov 29, 1994SESE
K945314CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBINGCleveland Tubing, Inc.Nov 18, 1994SESE
K944429PRECISION THERMOPLASTIC COMPONENETS, INC. TUBINGPrecision Thermoplastic Components, Inc.Nov 18, 1994SESE
K940890CORRUGATED TUBINGCleveland Tubing, Inc.Nov 10, 1994SESE
K940889CONNECTORS AND AIRWAY EXTENSIONSCleveland Tubing, Inc.Nov 10, 1994SESE
K944295KARL STORZ LARYNGOSCOPE ACCESSORIESKARL STORZ Endoscopy-America, Inc.Oct 4, 1994SESE
K942136M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITSMag, Inc.Jun 22, 1994SESE
K942135M.A.G. INC. COAXIAL CIRCUITSMag, Inc.Jun 22, 1994SESE
K942134M.A.G. INC. BREALTHING BAGSMag, Inc.Jun 22, 1994SESE
K942133M.A.G. INC. CUSTOM ANESTHESIA CIRCUITSMag, Inc.Jun 22, 1994SESE
K942132M.A.G. INC. HYPERINFLATION SYSTEMMag, Inc.Jun 22, 1994SESE
K942131M.A.G. INC. GUEDEL AIRWAYSMag, Inc.Jun 22, 1994SESE
K942130M.A.G. INC. MAPLESON D CIRCUITSMag, Inc.Jun 22, 1994SESE
K942129M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSMag, Inc.Jun 22, 1994SESE
K942128M.A.G. INC. ADULT GAS SAMPLING CIRCUITSMag, Inc.Jun 22, 1994SESE
K942127M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITSMag, Inc.Jun 22, 1994SESE
K942126M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUITMag, Inc.Jun 22, 1994SESE
K942125VOLUME VENTILATORMag, Inc.Jun 22, 1994SESE
K942124GAS SAMPLING LINES AND CONNECTORS CIRCUITSMag, Inc.Jun 22, 1994SESE
K942123M.A.G. INC. VENTILATOR HOSESMag, Inc.Jun 22, 1994SESE
K942122PEDIATRIC ANESTHESIA CIRCUITSMag, Inc.Jun 22, 1994SESE
K942570MAPLESON D CIRCUITMed-Plastics Intl., Inc.Jun 10, 1994SESE
K942568ADULT ANESTHESIA BREATHING CIRCUITMed-Plastics Intl., Inc.Jun 10, 1994SESE
K934462ADULT ANESTHESIA BREATHING CIRCUIT KITSZefon Medical ProductsMar 1, 1994SESK
K935168ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITSBill Olson Corp.Feb 7, 1994SESK
K932781DUAL VALVED RESPIRATORY TInnovations For Mechanical Ventilation, Inc.Jan 24, 1994SESE
K932780MALE/MALE LUER TRANSFER TUBINGInnovations For Mechanical Ventilation, Inc.Jan 24, 1994SESE
K931487BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVEBird Life DesignDec 16, 1993SESE
K935044EASYFLOW AIRWAY ADAPTEREasyflow Airway Systems, Inc.Nov 18, 1993SESE
K933641BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLEBird Life DesignOct 15, 1993SESE
K930713THE INFANT FLOW SYSTEMSechrist Industries, Inc.Sep 16, 1993SESE
K932710GAS SAMPLING LINES AND CONNECTORSPrecision Med Products, Ltd.Jul 23, 1993SESE
K932708PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITSPrecision Med Products, Ltd.Jul 23, 1993SESE
K932707ADULT ANESTHESIA BREATHING CIRCUITPrecision Med Products, Ltd.Jul 23, 1993SESE
K932562GAS SAMPLING LINES AND CONNECTORSLife Shield Healthcare Products, Inc.Jul 23, 1993SESE
K932590ADULT GAS SAMPLING CIRCUITSMerit Medical Systems, Inc.Jul 22, 1993SESE
K932589PEDIATRIC GAS SAMPLING CIRCUITSMerit Medical Systems, Inc.Jul 22, 1993SESE
K932578ADULT GAS SAMPLING CIRCUITSMed-Plastics Intl., Inc.Jul 22, 1993SESE
K932577PEDIATRIC GAS SAMPLINGMed-Plastics Intl., Inc.Jul 22, 1993SESE
K932576PEDIATRIC TEMPERATURE MONITORING CIRCUITSMed-Plastics Intl., Inc.Jul 22, 1993SESE
K932575ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSMed-Plastics Intl., Inc.Jul 22, 1993SESE
K932558ADULT ANESTHESIA BREATHING CIRCUITLife Shield Healthcare Products, Inc.Jul 22, 1993SESE
K932497PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLINGPrecision Med Products, Ltd.Jul 22, 1993SESE
K932489PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR.Precision Med Products, Ltd.Jul 22, 1993SESE
K932488PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITSPrecision Med Products, Ltd.Jul 22, 1993SESE
K932588PEDIATRIC TEMPERATURE MONITORING CIRCUITSMerit Medical Systems, Inc.Jul 21, 1993SESE
K932583ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSMerit Medical Systems, Inc.Jul 21, 1993SESE
K932486PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUITPrecision Med Products, Ltd.Jul 21, 1993SESE
K932587COAXIAL CIRCUITSMerit Medical Systems, Inc.Jul 16, 1993SESE
K932586CUSTOM ANESTHESIA CIRCUITSMerit Medical Systems, Inc.Jul 16, 1993SESE
K932585PEDIATRIC ANESTHESIA CIRCUITSMerit Medical Systems, Inc.Jul 16, 1993SESE
K932582CUSTOM ANESTHESIA CIRCUITSMed-Plastics Intl., Inc.Jul 16, 1993SESE
K932580PEDIATRIC ANESTHESIA CIRCUITSMed-Plastics Intl., Inc.Jul 16, 1993SESE
K932579COAXIAL CIRCUITSMed-Plastics Intl., Inc.Jul 16, 1993SESE
K932559MAPLESON D CIRCUITSLife Shield Healthcare Products, Inc.Jul 16, 1993SESE
K932490PMP, LTD. CUSTOM ANESTHESIA CIRCUITSPrecision Med Products, Ltd.Jul 14, 1993SESE
K932487PMP, LTD. PEDIATRIC ANESTHESIA CIRCUITSPrecision Med Products, Ltd.Jul 13, 1993SESE
K932485PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITSPrecision Med Products, Ltd.Jul 13, 1993SESE
K932197CUSTOM ANESTHESIA CIRCUITSLife Shield Healthcare Products, Inc.Jul 2, 1993SESE
K932196COAXIAL CIRCUITSLife Shield Healthcare Products, Inc.Jul 2, 1993SESE
K932195ADULT GAS SAMPLING CIRCUITSLife Shield Healthcare Products, Inc.Jul 2, 1993SESE
K932194PEDIATRIC GASSAMPLING CIRCUITSLife Shield Healthcare Products, Inc.Jul 2, 1993SESE
K932193PEDIATRIC TEMPERATURE MONITORING CIRCUITSLife Shield Healthcare Products, Inc.Jul 2, 1993SESE
K932192PEDIATRIC ANESTHESIA CIRCUITSLife Shield Healthcare Products, Inc.Jul 2, 1993SESE
K932190ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSLife Shield Healthcare Products, Inc.Jul 2, 1993SESE
K926454ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPONMedical, Inc.Jun 22, 1993SEKD
K922789KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUITKing Systems Corp.May 26, 1993SESE
K925543BLD-18000 SERIES HEATED BREATHING CIRCUITBird Life DesignApr 30, 1993SESE
K924627XTEND CIRCUITS (TM)Arc Medical, Inc.Apr 7, 1993SESE
K924889ZEFON ADULT ANESTHESIA BREATHING CIRCUITZefon Medical ProductsMar 19, 1993SESE
K925893OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUITOem Medical Div.Mar 12, 1993SESE
K930252BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)Bird Life DesignFeb 9, 1993SESE
K925231MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITSMerit Medical Systems, Inc.Jan 26, 1993SESE
K925232MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUITMerit Medical Systems, Inc.Jan 22, 1993SESE
K915452ANESTHESIA BREATHING CIRCUITConcord/PortexFeb 14, 1992SESE
K911880ZEFON ADULT ANESTHESIA BREATHING CIRCUITBill Olson Corp.Dec 20, 1991SESE
K913753BODAI NEO2 -SAFE AIRWAY PRESSURE CAPB&B Medical Technologies, Inc.Oct 23, 1991SESE
K912504DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIEDIntertech Resources, Inc.Oct 23, 1991SESE
K912065DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIEDIntertech Resources, Inc.Oct 23, 1991SESE
K91126322MM ID/OD ADAPTERMonaghan Medical Corp.Aug 19, 1991SESE
K911736MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUITMedical Assemblies, Inc.Jul 11, 1991SESE
K905450ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINEVital Signs, Inc.Jul 1, 1991SESE
K910896DISPOSABLE ANESTHESIA BREATHING CIRCUITSpecialty Packaging Producs, Inc.May 8, 1991SESE
K904538MAUNA LOA ENHANCED HEATED BREATHING CIRCUITMauna Loa Medical, Inc.Apr 24, 1991SESE
K905148TEMPERATURE PROBETec II Medical, Inc.Apr 1, 1991SESE
K901739THAYER METERED DOSE INHALER DISPENSER/ADAPTERThayer Medical Corp.Oct 9, 1990SESE
K900428ANESTHESIA BREATHING CIRCUITSMed-Tek Corp.Aug 17, 1990SESE
K900594ANESTHESIA BREATHING CIRCUITInhalation PlasticsMar 15, 1990SESE
K896897VENTLAB ANESTHESIA CIRCUIT AC 6000Ventlab Corp.Jan 26, 1990SESE
K896365BABYFLEX HEATED INFANT BREATHING CIRCUITBaxter Healthcare CorpJan 22, 1990SESE
K895357ANETHESIA BREATHING CIRCUITF.L.W. Plastics, Inc.Oct 19, 1989SESE
K893919ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAPBaxter Healthcare CorpSep 15, 1989SESE
K890499BIVONA VENTILATOR ISOLATOR SYSTEMBivona Medical TechnologiesJun 15, 1989SESE
K891479DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITSAnetec, Inc.May 5, 1989SESE
K88407215 MILLIMETER MALE AND FEMALE ADAPTERSEastmed Enterprises, Inc.Oct 7, 1988SESE
K881141PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUITBaxter Healthcare CorpApr 25, 1988SESE
K880683KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUITKing Systems Corp.Mar 9, 1988SESE
K873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEAmerican Pharmaseal Div. AhscNov 6, 1987SESE
K870859BAG-TAIL BLEED VALVEDryden Corp.Aug 3, 1987SESE
K871386BREATHING CIRCUITDryden Corp.May 29, 1987SESE
K871669BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVELife Design Systems, Inc.May 19, 1987SESE
K864588PENLON CIRCLE SYSTEMBear Medical Systems, Inc.Feb 3, 1987SESE
K862003CIRCUIT ANES. BREATHING & COMPONENTSVital Signs, Inc.Jul 7, 1986SESE
K861438CIRCUIT, ANES. BREATHING (NON-REBREATHING)Vital Signs, Inc.May 9, 1986SESE
K854573ANESTHESIA SHUTOFF VALVE POSITIVE CLOSUREArtec Environmental Monitoring DivisionJan 3, 1986SESE
K852632GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUBMedicomp, Inc.Jan 3, 1986SESE
K852866HYDRO-BAC FILTERMedicomp, Inc.Jan 1, 1986SESE
K852405LASERSAFE PERSONNEL AND PATIENT SHIELDSLasersafe, Inc.Oct 1, 1985SESE
K853065#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAGSigma Medical, Inc.Sep 3, 1985SESE
K8533444000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUITSigma Medical, Inc.Aug 29, 1985SESE
K8533433015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT WSigma Medical, Inc.Aug 29, 1985SESE
K8533426013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAGSigma Medical, Inc.Aug 29, 1985SESE
K852314#6010 NON-CONDUCTIVE VENTILATOR CIRCUITSigma Medical, Inc.Aug 13, 1985SESE
K852316#3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.Jul 15, 1985SESE
K852315#3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.Jul 15, 1985SESE
K852313#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.Jul 15, 1985SESE
K852312#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.Jul 15, 1985SESE
K852311#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.Jul 15, 1985SESE
K851193ANESTHESIA BREATHING CIRCUITAvatron, Inc.Jun 14, 1985SESE
K8515314013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAGSigma Medical, Inc.Apr 25, 1985SESE
K8515304003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GASSigma Medical, Inc.Apr 25, 1985SESE
K8515294010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIALSigma Medical, Inc.Apr 25, 1985SESE
K844149AMBU RUBEN CIRCLE ANESTHESIA SYSTEMAmbu, Inc.Nov 15, 1984SESE
K842492AMER. MEDICAL PLASTICS CO 20100American Medical Plastics Co.Jul 6, 1984SESE
K842488SAMSON 1000 ANESTHESIA CIRCUITJ. H. Emerson Co.Jul 6, 1984SESE
K841264BABYSET TM & PAC TM -PULMONARY ASSISTLife Design Systems, Inc.Jun 15, 1984SESE
K841455REUSEABLE NON-CONDUCTIVE FIXED YDryden Corp.Jun 11, 1984SESE
K840431SCRATCH & SNIFF FOR ANESTHESIADryden Corp.May 14, 1984SESE
K840740CIRCUIT BREATHINGMarquest Medical Products, Inc.Apr 17, 1984SESE
K840850ANESTHESIA VENTILATOR CIRCUITThe Kendal Co.Mar 19, 1984SESE
K840056PEDIATRIC INTUBATION CIRCUITAckrad LaboratoriesFeb 10, 1984SESE
K833871UNIVERSAL CONTROL ARMAnesthesia Assoc., Inc.Dec 27, 1983SESE
K833478HUMPHREY A.D.E. SYSTEMAnaesthetic Breathing SystemDec 16, 1983SESE
K833196VOLUME VENTILATOR CIRCUIT-NEBULIZERAirlife, Inc.Nov 3, 1983SESE
K833088SPIROMETER ISOLATION VALVE #8890Boehringer Mannheim Corp.Oct 28, 1983SESE
K832453SLIMB SINGLE LIMB BREATHING CIRCUITRespiratory Care, Inc.Oct 27, 1983SESE
K830475BRAIN MODULE RJ-Z10Instrumentation Industries, Inc.Jun 8, 1983SESE
K830470ANESTHESIA BREATHING CIRCUITSMon-A-Therm, Inc.Mar 24, 1983SESE
K823714DISPOSABLE NON-REBREATHING ANES. CIRCUITMarquest Medical Products, Inc.Jan 7, 1983SESE
K822769THORATEC GAS SAMPLING CONNECTORThoratec Laboratories Corp.Oct 6, 1982SESE
K822379DISPOSABLE ANESTHESIA BREATHING CIRCUITMarquest Medical Products, Inc.Aug 20, 1982SESE
K821311ESPREE' BREATHING CIRCUIT (W/ACCESSEsp Plastics, Inc.May 21, 1982SESE
K821087ANESTHESIA BREATHING CIRCUITLife Design Systems, Inc.May 14, 1982SESE
K821086M T M CIRCUITMedical Technology Mix, Inc.May 3, 1982SESE
K820352ANALGESIA BREATHING CIRCUITCryogentics Northwest, Inc.Mar 4, 1982SESE
K813382DISPOSABLE ADULT ANES. CIRCUITIntec.Jan 22, 1982SESE
K812624OXEQUIP CONDUCTIVE & NON ANES. BREATHOxequip Health Ind.Oct 26, 1981SESE
K811858KHI CPRAM BREATHING CIRCUITKhi, Inc.Jul 16, 1981SESE
K811700CIRCUIT, BREATHINGMarquest Medical Products, Inc.Jul 10, 1981SESE
K811413DABC NONCONDUCTIVE PEDIAT. ANESTH. CIRAirco/Ohio Medical ProductsJun 2, 1981SESE
K811015POSITIVE CLOSURE ANESTHETIC VALVEOrthopedic Systems, Inc.May 15, 1981SESE
K801191ANESTHESIA BREATHING CIRCUITSAirlife, Inc.May 28, 1980SESE
K801111PEDIATRIC ANESTHESIA CIRCUITVital Signs, Inc.May 23, 1980SESE
K800499PEDIATRIC ANESTHESIA BREATHING CIRCUITSAirlife, Inc.Mar 25, 1980SESE
K800498ADULT ANESTHESIA BREATHING CIRCUITS . .Airlife, Inc.Mar 25, 1980SESE
K792499AMBU PAEDI ANAESTHESIA SYSTEMNarco Air-ShieldsDec 19, 1979SESE
K790214MODIFIED JACKSON-REES CIRCUITVital Signs, Inc.Mar 19, 1979SESE
K790115BREATHING CIRCUIT, DISPOSABLEH.B. Laboratories, Inc.Mar 16, 1979SESE
K781908BREATHING CIRCUIT PRODUCTS, ANESTHESIAHospitak, Inc.Nov 27, 1978SESE
K780044BREATHING CIRCUIT, BAINRespiratory Care, Inc.Feb 2, 1978SESE
K771518INSPIRATORY FORCE ADAPTORVital Flow Products Corp.Aug 16, 1977SESE
K771307BAIN BREATHING CIRCUITRespiratory Care, Inc.Aug 4, 1977SESE
K771034HI-MID CURCUITDraeger Medical, Inc.Aug 4, 1977SESE
K771134ANESTHESIA BREATHING CIRCUITAir Products & Chemicals, Inc.Jul 5, 1977SESE
K771017CITADEL CPAP ACCESSORY KITSherwood Medical IndustriesJun 14, 1977SESE
K770838ANESTHESIA BREATHING CIRCUIT, DISPOSABLEOhio Medical ProductsMay 23, 1977SESE
K770549PEDIATRIC ANESTHESIA CIRCUITInspiron Corp.Mar 30, 1977SESE
K770286VENTILATOR BREATHING CIRCUITMcgaw Respiratory TherapyFeb 25, 1977SESE
K760819CONDUCTIVE ANESTHESIA BREATHING CIRCUITOmnicon Medical Corp.Oct 27, 1976SESE
K760565VENTILATOR CIRCUITSForegger Air Products & Chem., Inc.Sep 16, 1976SESE
K760149CONDUCTIVE ANESTHSIA BREATH. CIRCUITOmnicon Medical Corp.Jul 19, 1976SESE

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