Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological 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
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- K953784UNICOR, INC. CORRUGATED TUBING1Cleared 510(K)
- K953785UNICOR, INC. VENTILATOR HOSES1Cleared 510(K)
- K952011PRIMA BREATHING BAGS1Cleared 510(K)
- K952012PRIMA CUSTOM ANESTESIA CIRCUIT1Cleared 510(K)
- K952010PRIMA VENTILATOR HOSES1Cleared 510(K)
- K952022PRIMA VOLUMN VENTILATORSS1Cleared 510(K)
- K945740INFANT FLOW SYSTEM1Cleared 510(K)
- K944531PRIMA, INC. CORRUGATED TUBING1Cleared 510(K)
- K942569VENTILATOR HOSE1Cleared 510(K)
- K942572VOLUME VENTILATOR1Cleared 510(K)
- K935582TUBE, INHALER OXYGEN1Cleared 510(K)
- K934753STAR BREATHING CIRCUITS1Cleared 510(K)
- K932706PRECISION MED PRODUCTS LTD. VENTILATOR HOSE1Cleared 510(K)
- K932712PRECISION MED PRODUCTS LTD VOLUME VENTILATORS1Cleared 510(K)
- K932560VOLUME VENTILATORS1Cleared 510(K)
- K932563VENTILATOR HOSES1Cleared 510(K)
- K932119CLEVELAND TUBING, INC. VENTILATOR HOSES1Cleared 510(K)
- K922479DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED1Cleared 510(K)
- K921510GAS SAMPLING KIT MODIFICATION1Cleared 510(K)
- K911328UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION1Cleared 510(K)
- K903083NEONATAL VENTILATOR CIRCUIT1Cleared 510(K)
- K903055EXTENDED LIFE CIRCUITS1Cleared 510(K)
- K903404FLOCARE F1Cleared 510(K)
- K896439TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE1Cleared 510(K)
- K895853SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT1Cleared 510(K)
- K893760CRITERION I.V. VENTILATOR BREATHING CIRCUIT #10041Cleared 510(K)
- K890822CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)1Cleared 510(K)
- K890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING1Cleared 510(K)
- K884525PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT1Cleared 510(K)
- K882341QUICK CONNECT T ADAPTOR1Cleared 510(K)
- K880959LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY1Cleared 510(K)
- K880637BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES1Cleared 510(K)
- K874559BABYFLEX PATIENT CIRCUIT1Cleared 510(K)
- K873900PORTABLE VENTILATOR PATIENT CIRCUIT1Cleared 510(K)
- K873927REUSEABLE BREATHING TUBES1Cleared 510(K)
- K863756MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT1Cleared 510(K)
- K863910RAINCOAT1Cleared 510(K)
- K863033PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS1Cleared 510(K)
- K860659END TIDAL CO2 SAMPLING CIRCUIT1Cleared 510(K)
- K861286GAS SAMPLING KIT1Cleared 510(K)
- K860880VENTILATOR CIRCUITS (VARIOUS TYPES)1Cleared 510(K)
- K860879DISPOSABLE VENTILATOR CIRCUITS1Cleared 510(K)
- K850151L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT1Cleared 510(K)
- K850600CO-AX VENTILATOR CIRCUIT1Cleared 510(K)
- K850703SAF T FLO VENTILATOR TUBING1Cleared 510(K)
- K844290L100D PATIENT CIRCUIT DUAL LINE1Cleared 510(K)
- K843036PATIENT BREATHING CIRCUIT1Cleared 510(K)
- K842778AVATRON UNIVERSAL ADULT VOL. VENTILATOR1Cleared 510(K)
- K842389AVATRON DISPOSABLE I.P.P.B. CIRUCIT1Cleared 510(K)
- K841657PATIENT TUBING HYTREL SIEMENS-ELEMA1Cleared 510(K)
- K841722MASS SPECTROMETER INTERFACE1Cleared 510(K)
- K841637THREE PORT SENSOR MANIFOLD1Cleared 510(K)
- K841378VENT-WELL VENTILATOR TUBING1Cleared 510(K)
- K834569VENTILATORY FREQUENCY MONITOR1Cleared 510(K)
- K834570VOLUME VENTILATOR CIRCUIT W/WATER TRAP1Cleared 510(K)
- K833459COAXIAL VOL. VENTILATOR CIRCUIT1Cleared 510(K)
- K832681UNIVERSAL VOL. VENTILATOR 72 #16261Cleared 510(K)
- K830923TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA1Cleared 510(K)
- K830922TEMP-CHECK ADAPTOR, TEE-CONFIGURATION1Cleared 510(K)
- K830921TEMP-CHECK ADAPTOR, Y-CONFIGURATION1Cleared 510(K)
- K823481BE #16 - MANIFOLD1Cleared 510(K)
- K823271DISPOSABLE ADULT VO. VENTILATOR CIRCUIT1Cleared 510(K)
- K823479MODUFLEX NEONATAL VENTILATOR SET1Cleared 510(K)
- K823287RESPIRATORY CIRCUIT ADAPTOR1Cleared 510(K)
- K821064INSPIRON NEONATAL VENTILATOR CIRCUIT1Cleared 510(K)
- K820128UNI-SET1Cleared 510(K)
- K8201313M VOLUME VENTIATOR CIRCUIT1Cleared 510(K)
- K813384DISPOSABLE NEONATAL VENTILATION CIRCUIT1Cleared 510(K)
- K813155PEDIATRIC VENTILATOR CIRCUIT 2C71311Cleared 510(K)
- K812773BENNETT VOLUME VENTILATOR CIRCUIT1Cleared 510(K)
- K812774VENTILATOR CIRCUIT1Cleared 510(K)
- K812737RAIN-X1Cleared 510(K)
- K810341LIFELINE IPPB SET-UP1Cleared 510(K)
- K801859CAM-10 RESPIRATORY HOSE ASSEMBLIES1Cleared 510(K)
- K801087NEONATAL BREATHING CIRCUIT SYSTEM1Cleared 510(K)
- K792268CIRCAPAK1Cleared 510(K)
- K792047CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,1Cleared 510(K)
- K792030TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT1Cleared 510(K)
- K791761CIRCUIT, BREATHING W/WO NEBULIZER1Cleared 510(K)
- K791856Y & ELBOW W/WO PORTS1Cleared 510(K)
- K791469MANIFOLD/NEBULIZER BREATHING PRODUCTS1Cleared 510(K)
- K791060RAIN-X1Cleared 510(K)
- K791034PIGGYBACK BREATHING CIRCUIT1Cleared 510(K)
- K772069VOL. VENTILATOR SETUP W/OUT NEBULIZER1Cleared 510(K)
- K770593CORRUGATED TUBING #770 & 7711Cleared 510(K)
- K770581CORRUGATED TUBING, 770 & 7711Cleared 510(K)
- K770354TUBING, AEROSAL, DISPOSABLE1Cleared 510(K)
- K760993MECK/MILLER VENTILATION TUBE HARNESS1Cleared 510(K)
- 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
- SDSCompression-Based Airway Clearance Device2Product Code
- SDTIntra-Pulmonary Percussive Vibration (Ipv) Devices2Product Code
- SFPVentilator-Compatible Nebulizer2Product 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
NEONATAL BREATHING CIRCUIT SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K801087
- 510(k) Type
- Traditional
- Applicant
- ISOTHERMAL SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/23/1980
- Days to Decision
- 16 days