Anesthesiology (AN) FDA Submissions
Browse FDA 510(k), De Novo, and PMA medical device clearances for the Anesthesiology (AN) review panel, including product codes, regulations, and cleared devices.
CFR Parts: Part 868, Part 870
Subparts
- Part 868 Subpart B—Diagnostic Devices — 48 product codes
- Part 868 Subpart C—Monitoring Devices — 33 product codes
- Part 868 Subpart D — 1 product code
- Part 868 Subpart F—Therapeutic Devices — 132 product codes
- Part 868 Subpart G—Miscellaneous — 13 product codes
- Part 870 Subpart C—Cardiovascular Monitoring Devices — 1 product code
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| BXL | Algesimeter, Manual | 868.1030 | 1 | 1 |
| BSI | Algesimeter, Powered | 868.1040 | 2 | 0 |
| JEG | Analyzer, Gas, Argon, Gaseous-Phase | 868.1075 | 2 | 1 |
| CBT | Arterial Blood Sampling Kit | 868.1100 | 1 | 58 |
| OFZ | Blood Specimen Collection Kit (Excludes Hiv Testing) | 868.1100 | 1 | 0 |
| JED | Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling | 868.1120 | 3 | 0 |
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 868.1150 | 2 | 15 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 868.1170 | 2 | 10 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 868.1200 | 2 | 23 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 868.1400 | 2 | 304 |
| OGK | Orotracheal Intubation Guide Kit | 868.1400 | 2 | 0 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 868.1430 | 2 | 27 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 22 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 0 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 1 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 0 |
| QEB | Ventilatory Electrical Impedance Tomograph | 868.1505 | 2 | 6 |
| KGK | Gas, Collecting Vessel | 868.1575 | 1 | 2 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 868.1620 | 2 | 17 |
| BSE | Analyzer, Gas, Helium, Gaseous-Phase | 868.1640 | 2 | 3 |
| JEF | Analyzer, Gas, Neon, Gaseous-Phase | 868.1670 | 2 | 0 |
| CCI | Analyzer, Gas, Nitrogen, Gaseous-Phase | 868.1690 | 2 | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 868.1700 | 2 | 5 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 868.1720 | 2 | 121 |
| BZL | Computer, Oxygen-Uptake | 868.1730 | 2 | 33 |
| CCM | Plethysmograph, Pressure | 868.1750 | 2 | 11 |
| JEH | Plethysmograph, Volume | 868.1760 | 2 | 11 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | 868.1780 | 2 | 6 |
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | 868.1800 | 2 | 12 |
| BZG | Spirometer, Diagnostic | 868.1840 | 2 | 228 |
| PNV | Impedance Measuring Device Utilizing Oscillation Techniques | 868.1840 | 2 | 4 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 868.1850 | 2 | 61 |
| BZH | Meter, Peak Flow, Spirometry | 868.1860 | 2 | 79 |
| BXW | Calibrator, Volume, Gas | 868.1870 | 1 | 6 |
| BZC | Calculator, Pulmonary Function Data | 868.1880 | 2 | 90 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 868.1890 | 2 | 63 |
| NDC | Calculator, Drug Dose | 868.1890 | 2 | 53 |
| PDT | Burn Resuscitation Decision Support Software | 868.1890 | 2 | 2 |
| PHY | Sparse Sample Pk Profile And Dosing Software | 868.1890 | 2 | 0 |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 868.1900 | 2 | 26 |
| PHZ | Abnormal Breath Sound Device | 868.1900 | 2 | 6 |
| BZW | Stethoscope, Esophageal | 868.1910 | 1 | 13 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 868.1920 | 2 | 46 |
| BZS | Stethoscope Head | 868.1930 | 1 | 3 |
| JFE | Valve, Switching (Ploss) | 868.1965 | 1 | 0 |
| BXA | Analyzer, Gas, Water Vapor, Gaseous-Phase | 868.1975 | 1 | 2 |
| QRG | Ultrasound Guided Nerve Block Assist | 868.1980 | 2 | 3 |
| QXD | Spinal Imaging System For Neuraxial Procedures | 868.1985 | 2 | 1 |
| CBA | Monitor, Air Embolism, Ultrasonic | 868.2025 | 2 | 1 |
| QVE | Adjunctive Pain Measurement Device For Anesthesiology | 868.2200 | 2 | 1 |
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | 868.2250 | 2 | 1 |
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | 868.2300 | 1 | 9 |
| BYM | Tube, Thorpe, Uncompensated | 868.2320 | 1 | 1 |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 868.2340 | 1 | 24 |
| BXY | Flowmeter, Calibration, Gas | 868.2350 | 1 | 7 |
| BZQ | Monitor, Breathing Frequency | 868.2375 | 2 | 174 |
| MNR | Ventilatory Effort Recorder | 868.2375 | 2 | 160 |
| PRK | Device Indicating An Exhalation Event | 868.2375 | 2 | 1 |
| FLS | Monitor, Apnea, Facility Use | 868.2377 | 2 | 16 |
| NPF | Monitor, Apnea, Home Use | 868.2377 | 2 | 2 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 868.2378 | 2 | 2 |
| MRP | Analyzer, Nitric Oxide | 868.2380 | 2 | 1 |
| MRQ | Analyzer, Nitrogen Dioxide | 868.2385 | 2 | 0 |
| PUG | Analyzer, Nitrogen Dioxide, Exempt | 868.2385 | 2 | 0 |
| JEZ | Monitor, Lung Water Measurement | 868.2450 | 3 | 1 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 868.2480 | 2 | 17 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 868.2500 | 2 | 47 |
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | 868.2500 | 2 | 2 |
| JAX | Pneumotachometer | 868.2550 | 2 | 8 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 868.2600 | 2 | 78 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 868.2610 | 1 | 4 |
| PXE | Pressure Monitoring (Air/Gas) Kit | 868.2610 | 1 | 0 |
| BXX | Calibrator, Pressure, Gas | 868.2620 | 1 | 10 |
| CAN | Regulator, Pressure, Gas Cylinder | 868.2700 | 1 | 55 |
| ECX | Cylinder, Compressed Gas, And Valve | 868.2700 | 1 | 13 |
| BXM | Stimulator, Nerve, Ac-Powered | 868.2775 | 2 | 4 |
| BXN | Stimulator, Nerve, Battery-Powered | 868.2775 | 2 | 63 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 868.2775 | 2 | 28 |
| BYR | Transducer, Gas Pressure, Differential | 868.2875 | 1 | 3 |
| BXP | Transducer, Gas Flow | 868.2885 | 1 | 7 |
| BXO | Transducer, Gas Pressure | 868.2900 | 1 | 2 |
| SDB | Tracheal Prosthesis With Cover Material Derived From Human Sources | 868.3721 | 2 | 1 |
| BWC | Needle, Emergency Airway | 868.5090 | 2 | 14 |
| QCX | Retrograde Intubation Set | 868.5095 | 2 | 1 |
| BTQ | Airway, Nasopharyngeal | 868.5100 | 1 | 19 |
| PMB | External Airway | 868.5105 | 2 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 868.5110 | 1 | 57 |
| PHS | Oral Airway Assist | 868.5110 | 1 | 0 |
| MZT | Device, Heimlich Maneuver Assist | 868.5115 | 2 | 1 |
| BSO | Catheter, Conduction, Anesthetic | 868.5120 | 2 | 75 |
| MAJ | Catheter, Percutaneous, Intraspinal, Short Term | 868.5120 | 2 | 6 |
| OFQ | Anesthesia Kit | 868.5120 | 2 | 0 |
| OFT | Spinal Epidural Anesthesia Kit | 868.5120 | 2 | 0 |
| OFU | Spinal Anesthesia Kit | 868.5120 | 2 | 0 |
| OFV | Regional Anesthesia Kit | 868.5120 | 2 | 0 |
| OGD | Custom Anesthesia Tray | 868.5120 | 2 | 0 |
| OGE | Epidural Anesthesia Kit | 868.5120 | 2 | 0 |
| OGF | Glossopharyngeal Anesthesia Kit | 868.5120 | 2 | 0 |
| BSN | Filter, Conduction, Anesthetic | 868.5130 | 2 | 9 |
| CAZ | Anesthesia Conduction Kit | 868.5140 | 2 | 155 |
| OGA | Brachial Plexus Anesthesia Kit | 868.5140 | 2 | 0 |
| OGB | Caudal Anesthesia Kit | 868.5140 | 2 | 0 |
| OGJ | Nerve Block Tray | 868.5140 | 2 | 0 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 868.5150 | 2 | 152 |
| MIA | Needle, Spinal, Short Term | 868.5150 | 2 | 10 |
| NMR | Needle, Spinal, Short Term, Reprocessed | 868.5150 | 2 | 0 |
| NNH | Needle, Conduction, Anesthesia, Reprocessed | 868.5150 | 2 | 0 |
| OGC | Continuous Brachial Plexus Block Tray | 868.5150 | 2 | 0 |
| BSZ | Gas-Machine, Anesthesia | 868.5160 | 2 | 187 |
| MRN | Apparatus, Nitric Oxide Delivery | 868.5165 | 2 | 33 |
| MRO | Apparatus, Nitric Oxide, Backup Delivery | 868.5165 | 2 | 4 |
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | 868.5170 | 2 | 10 |
| CCO | Bed, Rocking, Breathing Assist | 868.5180 | 2 | 0 |
| BYO | Bottle, Blow | 868.5220 | 1 | 4 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 868.5240 | 1 | 184 |
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | 868.5240 | 1 | 0 |
| CAG | Circulator, Breathing-Circuit | 868.5250 | 2 | 0 |
| CAH | Filter, Bacterial, Breathing-Circuit | 868.5260 | 2 | 200 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 868.5270 | 2 | 45 |
| QBY | Positive Airway Pressure System | 868.5273 | 2 | 2 |
| JAY | Support, Breathing Tube | 868.5280 | 1 | 19 |
| CBL | Absorbent, Carbon-Dioxide | 868.5300 | 1 | 5 |
| BSF | Absorber, Carbon-Dioxide | 868.5310 | 1 | 8 |
| BTC | Bag, Reservoir | 868.5320 | 1 | 19 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 868.5330 | 2 | 55 |
| CAT | Cannula, Nasal, Oxygen | 868.5340 | 1 | 42 |
| BZB | Catheter, Nasal, Oxygen | 868.5350 | 1 | 8 |
| BYN | Chair, Posture, For Cardiac And Pulmonary Treatment | 868.5365 | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 868.5375 | 1 | 73 |
| BWL | Apparatus, Electronanesthesia | 868.5400 | 3 | 0 |
| BTB | Hook, Ether | 868.5420 | 1 | 0 |
| BTP | Dropper, Ether | 868.5420 | 1 | 1 |
| CBN | Apparatus, Gas-Scavenging | 868.5430 | 2 | 43 |
| CAW | Generator, Oxygen, Portable | 868.5440 | 2 | 284 |
| OLF | Medevac Use Oxygen Generator | 868.5440 | 2 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 868.5450 | 2 | 221 |
| OBN | Humidifier, Respiratory, Mask (Direct Patient Interface) | 868.5450 | 2 | 1 |
| OGG | Humidifier Nebulizer Kit | 868.5450 | 2 | 0 |
| QAV | High Flow/High Velocity Humidified Oxygen Delivery Device | 868.5454 | 2 | 3 |
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 868.5460 | 1 | 20 |
| CBF | Chamber, Hyperbaric | 868.5470 | 2 | 69 |
| CAL | Laryngoscope, Non-Rigid | 868.5530 | 1 | 8 |
| CCW | Laryngoscope, Rigid | 868.5540 | 1 | 64 |
| OGH | Laryngoscope Kit | 868.5540 | 1 | 0 |
| BSJ | Mask, Gas, Anesthetic | 868.5550 | 1 | 51 |
| BTK | Strap, Head, Gas Mask | 868.5560 | 1 | 6 |
| KGB | Mask, Oxygen, Non-Rebreathing | 868.5570 | 1 | 13 |
| BYG | Mask, Oxygen | 868.5580 | 1 | 55 |
| KHA | Mask, Scavenging | 868.5590 | 1 | 1 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 868.5600 | 1 | 19 |
| BYP | Mouthpiece, Breathing | 868.5620 | 1 | 25 |
| CAF | Nebulizer (Direct Patient Interface) | 868.5630 | 2 | 507 |
| NVO | Spacer, Direct Patient Interface | 868.5630 | 2 | 2 |
| NVP | Holding Chambers, Direct Patient Interface | 868.5630 | 2 | 16 |
| SFP | Ventilator-Compatible Nebulizer | 868.5630 | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 868.5640 | 1 | 62 |
| CAO | Airway, Esophageal (Obturator) | 868.5650 | 2 | 6 |
| BYJ | Unit, Liquid-Oxygen, Portable | 868.5655 | 2 | 55 |
| OGL | Oxygen Administration Kit | 868.5655 | 2 | 0 |
| BYI | Percussor, Powered-Electric | 868.5665 | 2 | 57 |
| SDS | Compression-Based Airway Clearance Device | 868.5665 | 2 | 0 |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | 868.5665 | 2 | 3 |
| BYW | Device, Rebreathing | 868.5675 | 1 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 868.5690 | 2 | 108 |
| BYL | Tent, Oxygen | 868.5700 | 1 | 11 |
| FOG | Hood, Oxygen, Infant | 868.5700 | 1 | 9 |
| BYK | Tent, Oxygen, Electrically Powered | 868.5710 | 2 | 3 |
| FNC | Tent, Pediatric Aerosol | 868.5710 | 2 | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 868.5720 | 2 | 6 |
| BTR | Tube, Tracheal (W/Wo Connector) | 868.5730 | 2 | 240 |
| LNZ | Changer, Tube, Endotracheal | 868.5730 | 2 | 2 |
| NMA | Tube, Tracheal, Reprocessed | 868.5730 | 2 | 0 |
| OQU | Airway Monitoring System | 868.5730 | 2 | 3 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 868.5740 | 2 | 34 |
| BSK | Cuff, Tracheal Tube, Inflatable | 868.5750 | 2 | 39 |
| CBG | Spreader, Cuff | 868.5760 | 1 | 1 |
| CBH | Device, Fixation, Tracheal Tube | 868.5770 | 1 | 47 |
| OGI | Nasal Endotracheal Tube Holder Kit | 868.5770 | 1 | 0 |
| BWB | Forceps, Tube Introduction | 868.5780 | 1 | 6 |
| BSR | Stylet, Tracheal Tube | 868.5790 | 1 | 32 |
| EPE | Brush, Cleaning, Tracheal Tube | 868.5795 | 1 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 868.5800 | 2 | 128 |
| JOH | Tube Tracheostomy And Tube Cuff | 868.5800 | 2 | 109 |
| NXA | Tracheotomy Care Kit | 868.5800 | 2 | 1 |
| OGP | Cricothyrotomy Kit | 868.5800 | 2 | 0 |
| OGV | Tracheostomy Cleaning Tray | 868.5800 | 2 | 0 |
| OGW | Tracheostomy Kit | 868.5800 | 2 | 0 |
| BZA | Connector, Airway (Extension) | 868.5810 | 1 | 94 |
| BRW | Protector, Dental | 868.5820 | 1 | 3 |
| CAC | Apparatus, Autotransfusion | 868.5830 | 2 | 195 |
| BYX | Tubing, Pressure And Accessories | 868.5860 | 1 | 62 |
| CBP | Valve, Non-Rebreathing | 868.5870 | 2 | 103 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 868.5880 | 2 | 57 |
| CBK | Ventilator, Continuous, Facility Use | 868.5895 | 2 | 504 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 868.5895 | 2 | 47 |
| MNT | Sv70 Ventilator | 868.5895 | 2 | 25 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 868.5895 | 2 | 13 |
| NOU | Continuous, Ventilator, Home Use | 868.5895 | 2 | 7 |
| NQY | Ventilator, Continuous, Minimal Ventilatory Support, Home Use | 868.5895 | 2 | 0 |
| ONZ | Mechanical Ventilator | 868.5895 | 2 | 6 |
| SGR | Noninvasive Positive Airway Pressure System, Facility Use | 868.5895 | 2 | 2 |
| BZD | Ventilator, Non-Continuous (Respirator) | 868.5905 | 2 | 456 |
| NFB | Conserver, Oxygen | 868.5905 | 2 | 71 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 868.5905 | 2 | 24 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 868.5905 | 2 | 10 |
| NMC | Mask, Ventilator, Non-Continuous, Reprocessed | 868.5905 | 2 | 0 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 868.5915 | 2 | 209 |
| OEV | Cardiopulmonary Resuscitation Aid Kit | 868.5915 | 2 | 0 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 868.5925 | 2 | 100 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 868.5935 | 2 | 21 |
| CBO | Attachment, Intermittent Mandatory Ventilation (Imv) | 868.5955 | 2 | 15 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 868.5965 | 2 | 80 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 868.5975 | 1 | 88 |
| BYH | Drain, Tee (Water Trap) | 868.5995 | 1 | 22 |
| BRY | Cabinet, Table And Tray, Anesthesia | 868.6100 | 1 | 5 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 868.6175 | 1 | 8 |
| BXJ | Clip, Nose | 868.6225 | 1 | 4 |
| BTI | Compressor, Air, Portable | 868.6250 | 2 | 74 |
| BXK | Gas, Calibration (Specified Concentration) | 868.6400 | 1 | 32 |
| BRX | Stool, Anesthesia | 868.6700 | 1 | 1 |
| BSY | Catheters, Suction, Tracheobronchial | 868.6810 | 1 | 116 |
| OFO | Airway Suction Kit | 868.6810 | 1 | 0 |
| OFR | Tracheobronchial Suction Catheter Kit | 868.6810 | 1 | 0 |
| OFS | Tracheal Suction Set | 868.6810 | 1 | 0 |
| OYI | Non-Bronchoscopic Bronchoalveolar Lavage Catheter | 868.6810 | 1 | 1 |
| CCX | Support, Patient Position | 868.6820 | 1 | 8 |
| CAM | Yoke Assembly, Medical Gas | 868.6885 | 1 | 8 |
| QWE | Hyperoxia Monitoring Device Adjunct To Pulse Oximetry | 870.2720 | 2 | 1 |
