FDA product codes
The device classification tree, in product code order.
FDA classifies every device type under a three-letter product code, and that code is what ties a clearance to a recall to a registered listing. Each page here carries the FDA definition, the regulation it sits under, clearance volume by year, and the companies that list the code with FDA.
Data as of , the FDA export date. FDA product classification database
Review panels
6,880 codes| Review panel | Panel code | Product codes |
|---|---|---|
| Anesthesiology | AN | 262 |
| Cardiovascular | CV | 437 |
| Clinical Chemistry | CH | 527 |
| Clinical Toxicology | TX | 338 |
| Dental | DE | 352 |
| Ear, Nose, Throat | EN | 269 |
| Gastroenterology, Urology | GU | 614 |
| General Hospital | HO | 394 |
| General, Plastic Surgery | SU | 562 |
| Hematology | HE | 281 |
| Immunology | IM | 278 |
| Medical Genetics | MG | 7 |
| Microbiology | MI | 554 |
| Neurology | NE | 291 |
| Obstetrics/Gynecology | OB | 269 |
| Ophthalmic | OP | 345 |
| Orthopedic | OR | 349 |
| Pathology | PA | 325 |
| Physical Medicine | PM | 210 |
| Radiology | RA | 216 |
| Code | Device name | Class | Regulation | Clearances | Recalls |
|---|---|---|---|---|---|
| BRT | Restraint, Patient, Conductive | Class I | 21 CFR 880.6760 | 0 | 0 |
| BRW | Protector, Dental | Class I | 21 CFR 868.5820 | 3 | 0 |
| BRX | Stool, Anesthesia | Class I | 21 CFR 868.6700 | 1 | 1 |
| BRY | Cabinet, Table And Tray, Anesthesia | Class I | 21 CFR 868.6100 | 5 | 99 |
| BRZ | Set, Blood Transfusion | Class II | 21 CFR 880.5440 | 30 | 24 |
| BSA | Warmer, Blood, Electromagnetic Radiation | Class III | 21 CFR 864.9205 | 0 | 0 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | Class II | 21 CFR 864.9205 | 14 | 2 |
| BSD | Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling | Class III | 0 | 0 | |
| BSE | Analyzer, Gas, Helium, Gaseous-Phase | Class II | 21 CFR 868.1640 | 3 | 0 |
| BSF | Absorber, Carbon-Dioxide | Class I | 21 CFR 868.5310 | 8 | 6 |
| BSI | Algesimeter, Powered | Class II | 21 CFR 868.1040 | 0 | 0 |
| BSJ | Mask, Gas, Anesthetic | Class I | 21 CFR 868.5550 | 51 | 1 |
| BSK | Cuff, Tracheal Tube, Inflatable | Class II | 21 CFR 868.5750 | 40 | 4 |
| BSN | Filter, Conduction, Anesthetic | Class II | 21 CFR 868.5130 | 9 | 1 |
| BSO | Catheter, Conduction, Anesthetic | Class II | 21 CFR 868.5120 | 75 | 119 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Class II | 21 CFR 868.5150 | 152 | 17 |
| BSR | Stylet, Tracheal Tube | Class I | 21 CFR 868.5790 | 32 | 16 |
| BSS | Tube, Nasogastric | Class II | 21 CFR 876.5980 | 13 | 5 |
| BST | Curette, Biopsy, Bronchoscope (Non-Rigid) | Class II | 21 CFR 874.4680 | 0 | 0 |
| BSY | Catheters, Suction, Tracheobronchial | Class I | 21 CFR 868.6810 | 116 | 89 |
| BSZ | Gas-Machine, Anesthesia | Class II | 21 CFR 868.5160 | 189 | 177 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | Class II | 21 CFR 878.4780 | 159 | 21 |
| BTB | Hook, Ether | Class I | 21 CFR 868.5420 | 0 | 0 |
| BTC | Bag, Reservoir | Class I | 21 CFR 868.5320 | 19 | 7 |
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | Class II | 21 CFR 874.4680 | 6 | 2 |
| BTI | Compressor, Air, Portable | Class II | 21 CFR 868.6250 | 74 | 5 |
| BTK | Strap, Head, Gas Mask | Class I | 21 CFR 868.5560 | 6 | 0 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Class II | 21 CFR 868.5925 | 100 | 29 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | Class II | 21 CFR 868.5915 | 209 | 97 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Class II | 21 CFR 868.5800 | 129 | 73 |
| BTP | Dropper, Ether | Class I | 21 CFR 868.5420 | 1 | 0 |
| BTQ | Airway, Nasopharyngeal | Class I | 21 CFR 868.5100 | 19 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | Class II | 21 CFR 868.5730 | 242 | 227 |
| BTS | Tube, Bronchial (W/Wo Connector) | Class II | 21 CFR 868.5720 | 6 | 11 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Class II | 21 CFR 868.5450 | 222 | 70 |
| BTX | Board, Arm (With Cover), Sterile | Class I | 21 CFR 878.3910 | 13 | 0 |
| BTY | Calculator, Predicted Values, Pulmonary Function | Class II | 21 CFR 868.1890 | 64 | 4 |
| BWA | Unit, Electrosurgical And Coagulation, With Accessories | Class II | 21 CFR 878.4400 | 3 | 0 |
| BWB | Forceps, Tube Introduction | Class I | 21 CFR 868.5780 | 6 | 1 |
| BWC | Needle, Emergency Airway | Class II | 21 CFR 868.5090 | 14 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | Class II | 21 CFR 868.5690 | 108 | 1 |
| BWH | Forceps, Biopsy, Bronchoscope (Non-Rigid) | Class II | 21 CFR 874.4680 | 6 | 0 |
| BWJ | Locator, Acupuncture Point | Class II | 21 CFR 880.5580 | 3 | 0 |
| BWK | Stimulator, Electro-Acupuncture | Unclassified | 23 | 0 | |
| BWL | Apparatus, Electronanesthesia | Class III | 21 CFR 868.5400 | 0 | 0 |
| BWN | Table And Attachments, Operating-Room | Class I | 21 CFR 878.4950 | 20 | 74 |
| BWP | Shoe And Shoe Cover, Conductive | Class I | 21 CFR 878.4040 | 3 | 0 |
| BXA | Analyzer, Gas, Water Vapor, Gaseous-Phase | Class I | 21 CFR 868.1975 | 2 | 0 |
| BXB | Exerciser, Powered | Class I | 21 CFR 890.5380 | 160 | 6 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | Class I | 21 CFR 868.2610 | 4 | 1 |
| BXJ | Clip, Nose | Class I | 21 CFR 868.6225 | 4 | 0 |
| BXK | Gas, Calibration (Specified Concentration) | Class I | 21 CFR 868.6400 | 32 | 0 |
| BXL | Algesimeter, Manual | Class I | 21 CFR 868.1030 | 1 | 0 |
| BXM | Stimulator, Nerve, Ac-Powered | Class II | 21 CFR 868.2775 | 4 | 0 |
| BXN | Stimulator, Nerve, Battery-Powered | Class II | 21 CFR 868.2775 | 63 | 5 |
| BXO | Transducer, Gas Pressure | Class I | 21 CFR 868.2900 | 2 | 0 |
| BXP | Transducer, Gas Flow | Class I | 21 CFR 868.2885 | 7 | 0 |
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | Class II | 21 CFR 868.1800 | 12 | 0 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | Class II | 21 CFR 868.1780 | 6 | 0 |
| BXW | Calibrator, Volume, Gas | Class I | 21 CFR 868.1870 | 6 | 0 |
| BXX | Calibrator, Pressure, Gas | Class I | 21 CFR 868.2620 | 10 | 0 |
| BXY | Flowmeter, Calibration, Gas | Class I | 21 CFR 868.2350 | 7 | 0 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | Class I | 21 CFR 868.5375 | 73 | 15 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Class II | 21 CFR 868.5965 | 80 | 10 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | Class I | 21 CFR 868.5600 | 19 | 3 |
| BYG | Mask, Oxygen | Class I | 21 CFR 868.5580 | 55 | 41 |
| BYH | Drain, Tee (Water Trap) | Class I | 21 CFR 868.5995 | 22 | 2 |
| BYI | Percussor, Powered-Electric | Class II | 21 CFR 868.5665 | 58 | 3 |
| BYJ | Unit, Liquid-Oxygen, Portable | Class II | 21 CFR 868.5655 | 55 | 6 |
| BYK | Tent, Oxygen, Electrically Powered | Class II | 21 CFR 868.5710 | 3 | 0 |
| BYL | Tent, Oxygen | Class I | 21 CFR 868.5700 | 11 | 1 |
| BYM | Tube, Thorpe, Uncompensated | Class I | 21 CFR 868.2320 | 1 | 0 |
| BYN | Chair, Posture, For Cardiac And Pulmonary Treatment | Class I | 21 CFR 868.5365 | 1 | 0 |
| BYO | Bottle, Blow | Class I | 21 CFR 868.5220 | 4 | 0 |
| BYP | Mouthpiece, Breathing | Class I | 21 CFR 868.5620 | 25 | 0 |
| BYR | Transducer, Gas Pressure, Differential | Class I | 21 CFR 868.2875 | 3 | 0 |
| BYS | Oxygenator, Long Term Support Greater Than 6 Hours | Class II | 21 CFR 870.4100 | 3 | 2 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | Class II | 21 CFR 868.5935 | 21 | 0 |
| BYW | Device, Rebreathing | Class I | 21 CFR 868.5675 | 2 | 1 |
| BYX | Tubing, Pressure And Accessories | Class I | 21 CFR 868.5860 | 62 | 1 |
| BYY | Tube, Aspirating, Flexible, Connecting | Class II | 21 CFR 880.6740 | 24 | 6 |
| BYZ | Trap, Sterile Specimen | Class II | 21 CFR 880.6740 | 9 | 1 |
| BZA | Connector, Airway (Extension) | Class I | 21 CFR 868.5810 | 94 | 38 |
| BZB | Catheter, Nasal, Oxygen | Class I | 21 CFR 868.5350 | 8 | 1 |
| BZC | Calculator, Pulmonary Function Data | Class II | 21 CFR 868.1880 | 90 | 5 |
| BZD | Ventilator, Non-Continuous (Respirator) | Class II | 21 CFR 868.5905 | 462 | 83 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | Class II | 21 CFR 868.5270 | 46 | 7 |
| BZG | Spirometer, Diagnostic | Class II | 21 CFR 868.1840 | 228 | 1 |
| BZH | Meter, Peak Flow, Spirometry | Class II | 21 CFR 868.1860 | 81 | 0 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | Class II | 21 CFR 868.1850 | 62 | 3 |
| BZL | Computer, Oxygen-Uptake | Class II | 21 CFR 868.1730 | 33 | 0 |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | Class II | 21 CFR 868.1900 | 26 | 0 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Class I | 21 CFR 868.6175 | 8 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | Class I | 21 CFR 868.5975 | 88 | 23 |
| BZQ | Monitor, Breathing Frequency | Class II | 21 CFR 868.2375 | 176 | 3 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | Class II | 21 CFR 868.5330 | 55 | 3 |
| BZS | Stethoscope Head | Class I | 21 CFR 868.1930 | 3 | 0 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | Class II | 21 CFR 868.1920 | 46 | 4 |
| BZW | Stethoscope, Esophageal | Class I | 21 CFR 868.1910 | 13 | 0 |
| CAC | Apparatus, Autotransfusion | Class II | 21 CFR 868.5830 | 195 | 89 |
