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
- K233855AllPEP2Cleared 510(K)
- K221058LungTrainer (MD2 & MD3)2Cleared 510(K)
- K222018Breathe+2Cleared 510(K)
- K220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser2Cleared 510(K)
- K203378Pulsehaler2Cleared 510(K)
- K192000D R Burton OxyPAP2Cleared 510(K)
- K181660Acapella Choice Blue Vibratory PEP Device2Cleared 510(K)
- K183108Combined Aerobika OPEP and VersaPAP device2Cleared 510(K)
- K182847Hudson RCI Voldyne Volumetric Exerciser2Cleared 510(K)
- K173918VersaPAP Positive Airway Pressure (PAP) Device2Cleared 510(K)
- K172388VPOD ITPR2Cleared 510(K)
- K160837MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM2Cleared 510(K)
- K163091VibraPEP2Cleared 510(K)
- K160636iPEP System and vPEP2Cleared 510(K)
- K150044O-PEP2Cleared 510(K)
- K153441VibraPEP2Cleared 510(K)
- K150173Aerobika OPEP Devive with Manometer2Cleared 510(K)
- K140772AEROSURE MEDIC2Cleared 510(K)
- K141355VOLUMETRIC INCENTIVE SPIROMETER2Cleared 510(K)
- K133873TRIBALL INCENTIVE SPIROMETER2Cleared 510(K)
- K123400AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE2Cleared 510(K)
- K091557LUNG FLUTE THERAPEUTIC2Cleared 510(K)
- K090829PARI PEP S2Cleared 510(K)
- K080299RESPIFIT S, MODEL RS-LR10010042Cleared 510(K)
- K070490CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)2Cleared 510(K)
- K053149SPIRO-BALL2Cleared 510(K)
- K040084LIFESTYLE CIRCULATORY ENHANCER2Cleared 510(K)
- K033401MODIFICATION TO RESQPOD CIRCULATORY ENHANCER2Cleared 510(K)
- K022906RESQPOD CIRCULATORY ENHANCER2Cleared 510(K)
- K012368AEROPEP2Cleared 510(K)
- K002768ACAPELLA2Cleared 510(K)
- K003146CLINIFLO INCENTIVE SPIROMETER2Cleared 510(K)
- K994074TRI-BALL2Cleared 510(K)
- K000314INCENTIVE SPIROMETER2Cleared 510(K)
- K992256FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-012Cleared 510(K)
- K991561ROADRUNNER, PEP THERAPY DEVICE2Cleared 510(K)
- K991300BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE2Cleared 510(K)
- K983308RC CORNET, MODEL #44F502Cleared 510(K)
- K984468VITAL PEP2Cleared 510(K)
- K983467THERAPEP2Cleared 510(K)
- K974848MINI-CISER2Cleared 510(K)
- K972824THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER2Cleared 510(K)
- K972042PARI PEP THERAPY SYSTEM2Cleared 510(K)
- K970596DHD EMERALD PRODUCT2Cleared 510(K)
- K954492MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX2Cleared 510(K)
- K962749THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT2Cleared 510(K)
- K961077PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE2Cleared 510(K)
- K953055MISTASSIST BREATHING EXERCISER2Cleared 510(K)
- K944412THE BREATHER2Cleared 510(K)
- K944344LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER2Cleared 510(K)
- K945118EXPIRATORY BREATHING EXERCISER2Cleared 510(K)
- K944900THERAPEP2Cleared 510(K)
- K942919MERCURY EXPIRATORY RESISTANCE EXERCISER2Cleared 510(K)
- K912943THRESHOLD 2X INSPIRATORY MUSCLE TRAINER2Cleared 510(K)
- K910138TVS II ELECTRONIC INCENTIVE SPIROMETER2Cleared 510(K)
- K903489THERA-MIST TM VOLUMINA INCENT SPIROMETER, P400002Cleared 510(K)
- K900754RESPIREX 22Cleared 510(K)
- K893665AEROSOL INHALATION MONITOR2Cleared 510(K)
- K873540AEROBICA - LUNG EXERCISER2Cleared 510(K)
- K873579AMBU RMT VALVE2Cleared 510(K)
- K871904TOTAL LUNG EXERCISER (TLE)2Cleared 510(K)
- K871742MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER2Cleared 510(K)
- K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER2Cleared 510(K)
- K864719PFLEX EM(TM) (EXERCISE MONITOR)2Cleared 510(K)
- K861564THE LUNG GYM (XLATOR AND NLATOR)2Cleared 510(K)
- K851334AIRLIFE ELECTRONIC INCENTIVE SPIROMETER2Cleared 510(K)
- K844963VITAPEP2Cleared 510(K)
- K842369ELECATH INFANT ARTERIAL & VENOUS CANNU2Cleared 510(K)
- K842634PFLEX RESPIRATORY MUSCLE EXERCISER2Cleared 510(K)
- K840239VOFLEX2Cleared 510(K)
- K840418INSPIRATORY/EXPIRATORY MUSCLE EXERCIS2Cleared 510(K)
- K833337VOLUREX II2Cleared 510(K)
- K833012INSPIROMETER2Cleared 510(K)
- K832878GOAL TENDER2Cleared 510(K)
- K831142INSPIRATORY RESISTOR KIT2Cleared 510(K)
- K821492BE#6006 VAR. RESIS. INSPIR. MUSCLE2Cleared 510(K)
- K822359SPI-RISE2Cleared 510(K)
- K821998RESPICORD2Cleared 510(K)
- K820528PFLEX TM2Cleared 510(K)
- K820606MONAGHAN'S TRUE VOLUME EXERCISER2Cleared 510(K)
- K813476OHIO VOLUME INCENTIVE SPIROMETER2Cleared 510(K)
- K810641K-MED ENCOURAGER INCENTIVE SPIROMETER2Cleared 510(K)
- K801199VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX2Cleared 510(K)
- K800546BUNN VOLUMAIRE RESPIRATORY EXERCISER2Cleared 510(K)
- K800386ARGYLE TRU-VOL2Cleared 510(K)
- K792598DISPOSABLE INCENTIVE SPIROMETER2Cleared 510(K)
- K792571COUNTER UNIT2Cleared 510(K)
- K792217AIR INCENTIVE SPIROMETER, W/NEBULIZER2Cleared 510(K)
- K792214MODEL TM2-BEHIND-THE-EAR TINNITUS2Cleared 510(K)
- K791842MOTIVATOR2Cleared 510(K)
- K791819AIR INCENTIVE SPIROMETER2Cleared 510(K)
- K791015VOLUREX TM2Cleared 510(K)
- K790744LUNG FUNCTION AMPLIFIER EXERCISER2Cleared 510(K)
- K781831SPIROMETER, INCENTIVE CATALOG # 17502Cleared 510(K)
- K782016SPIROCARE 108-B2Cleared 510(K)
- K781731INCENT-O-NEB2Cleared 510(K)
- K781838CALCULATOR, WITH CHARGER2Cleared 510(K)
- K781833EXERCISER, AIR-EZE INCENTIVE2Cleared 510(K)
- K781669RESPIRATORY EXERCISOR, VOLUME PULSE2Cleared 510(K)
- K781245LUNG EXER. BAG, POST-OP, MODIFIED2Cleared 510(K)
- K780265FLOW REDUCING ANGULATION STAND2Cleared 510(K)
- K780037EXERCISER, RESP., DEEP BREATHING2Cleared 510(K)
- K771532SPIROMETEO & LUNG EXERCISER, 46012Cleared 510(K)
- K770619EXERCISOR, RESPIRATORY2Cleared 510(K)
- K770141INSPIROMETER RESPIRATORY EXERCISER2Cleared 510(K)
- K760762INCENTIVE SPIROMETER2Cleared 510(K)
- K760167BAG, POST OPERATIVE LUNG EXERCIZING BLOW2Cleared 510(K)
- 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
- 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
THE BREATHER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K944412
- 510(k) Type
- Traditional
- Applicant
- PAL MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/26/1995
- Days to Decision
- 230 days
- Submission Type
- Statement