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 |
|---|---|---|---|---|---|
| DQB | Phlebograph, Impedance | Class II | 21 CFR 870.2750 | 3 | 0 |
| DQC | Phonocardiograph | Class I | 21 CFR 870.2390 | 18 | 0 |
| DQD | Stethoscope, Electronic | Class II | 21 CFR 870.1875 | 156 | 0 |
| DQE | Catheter, Oximeter, Fiber-Optic | Class II | 21 CFR 870.1230 | 19 | 14 |
| DQF | Actuator, Syringe, Injector Type | Class II | 21 CFR 870.1670 | 3 | 0 |
| DQG | Microsphere, Trace | Class III | 21 CFR 870.1360 | 0 | 0 |
| DQH | Cardiograph, Apex (Vibrocardiograph) | Class II | 21 CFR 870.2310 | 1 | 0 |
| DQI | Withdrawal/Infusion Pump | Class II | 21 CFR 870.1800 | 9 | 0 |
| DQK | Computer, Diagnostic, Programmable | Class II | 21 CFR 870.1425 | 438 | 125 |
| DQO | Catheter, Intravascular, Diagnostic | Class II | 21 CFR 870.1200 | 501 | 285 |
| DQP | Kit, Balloon Repair, Catheter | Class III | 21 CFR 870.1350 | 0 | 0 |
| DQR | Cannula, Catheter | Class II | 21 CFR 870.1300 | 25 | 26 |
| DQT | Occluder, Catheter Tip | Class II | 21 CFR 870.1370 | 12 | 4 |
| DQX | Wire, Guide, Catheter | Class II | 21 CFR 870.1330 | 768 | 258 |
| DQY | Catheter, Percutaneous | Class II | 21 CFR 870.1250 | 896 | 620 |
| DRA | Catheter, Steerable | Class II | 21 CFR 870.1280 | 42 | 10 |
| DRB | Stylet, Catheter | Class II | 21 CFR 870.1380 | 28 | 0 |
| DRC | Trocar | Class II | 21 CFR 870.1390 | 51 | 11 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | 21 CFR 870.1310 | 105 | 40 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Class II | 21 CFR 870.1220 | 185 | 26 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class II | 21 CFR 870.2910 | 192 | 12 |
| DRI | Monitor, Line Isolation | Class I | 21 CFR 870.2620 | 4 | 1 |
| DRJ | System, Signal Isolation | Class I | 21 CFR 870.2600 | 4 | 0 |
| DRK | Dc-Defibrillator, High Energy, (Including Paddles) | Class III | 21 CFR 870.5300 | 1 | 0 |
| DRL | Tester, Defibrillator | Class II | 21 CFR 870.5325 | 19 | 1 |
| DRM | Compressor, Cardiac, External | Class II | 21 CFR 870.5200 | 45 | 12 |
| DRN | Device, Counter-Pulsating, External | Class II | 21 CFR 870.5225 | 34 | 1 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | Class II | 21 CFR 870.5550 | 84 | 22 |
| DRP | Tourniquet, Automatic Rotating | Class II | 21 CFR 870.5925 | 0 | 0 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | Class II | 21 CFR 870.2060 | 27 | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | Class II | 21 CFR 870.2050 | 24 | 0 |
| DRS | Transducer, Blood-Pressure, Extravascular | Class II | 21 CFR 870.2850 | 149 | 236 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class II | 21 CFR 870.2300 | 340 | 11 |
| DRW | Adaptor, Lead Switching, Electrocardiograph | Class II | 21 CFR 870.2350 | 8 | 0 |
| DRX | Electrode, Electrocardiograph | Class II | 21 CFR 870.2360 | 329 | 20 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | Class II | 21 CFR 870.4330 | 47 | 40 |
| DRZ | Oscillometer | Class II | 21 CFR 870.2675 | 0 | 0 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Class II | 21 CFR 870.2900 | 105 | 12 |
| DSB | Plethysmograph, Impedance | Class II | 21 CFR 870.2770 | 115 | 2 |
| DSF | Recorder, Paper Chart | Class I | 21 CFR 870.2810 | 87 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | Class II | 21 CFR 870.2800 | 195 | 0 |
| DSI | Detector And Alarm, Arrhythmia | Class II | 21 CFR 870.1025 | 398 | 82 |
| DSJ | Alarm, Blood-Pressure | Class II | 21 CFR 870.1100 | 6 | 4 |
| DSK | Computer, Blood-Pressure | Class II | 21 CFR 870.1110 | 77 | 1 |
| DSM | Alarm, Leakage Current, Portable | Class I | 21 CFR 870.2640 | 1 | 0 |
| DSP | System, Balloon, Intra-Aortic And Control | Class II | 21 CFR 870.3535 | 162 | 194 |
| DSQ | Ventricular (Assist) Bypass | Class III | 0 | 131 | |
| DSR | Stimulator, Carotid Sinus Nerve | Class III | 21 CFR 870.3850 | 0 | 0 |
| DSS | Clip, Vascular | Class II | 21 CFR 870.3250 | 8 | 4 |
| DST | Clip, Vena-Cava | Class II | 21 CFR 870.3260 | 1 | 0 |
| DSW | Bag, Polymeric Mesh, Pacemaker | Class I | 21 CFR 870.3650 | 0 | 0 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Class II | 21 CFR 870.3450 | 188 | 87 |
| DSZ | Pacemaker Battery | Class III | 21 CFR 870.3610 | 0 | 2 |
| DTA | Tester, Pacemaker Electrode Function | Class II | 21 CFR 870.3720 | 10 | 2 |
| DTB | Permanent Pacemaker Electrode | Class III | 21 CFR 870.3680 | 487 | 8 |
| DTC | Analyzer, Pacemaker Generator Function | Class II | 21 CFR 870.3630 | 30 | 0 |
| DTD | Pacemaker Lead Adaptor | Class II | 21 CFR 870.3620 | 103 | 0 |
| DTE | Pulse-Generator, Pacemaker, External | Class II | 21 CFR 870.3600 | 65 | 5 |
| DTF | Tools, Pacemaker Service | Class I | 21 CFR 870.3730 | 2 | 0 |
| DTG | Magnet, Test, Pacemaker | Class I | 21 CFR 870.3690 | 5 | 0 |
| DTH | Suture, Cardiovascular | Class III | 0 | 1 | |
| DTI | Sizer, Heart-Valve, Prosthesis | Class I | 21 CFR 870.3945 | 7 | 2 |
| DTJ | Holder, Heart-Valve, Prosthesis | Class I | 21 CFR 870.3935 | 12 | 1 |
| DTK | Filter, Intravascular, Cardiovascular | Class II | 21 CFR 870.3375 | 83 | 22 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class II | 21 CFR 870.4290 | 137 | 59 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | Class II | 21 CFR 870.4260 | 96 | 5 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | Class II | 21 CFR 870.4400 | 169 | 47 |
| DTP | Defoamer, Cardiopulmonary Bypass | Class II | 21 CFR 870.4230 | 34 | 0 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | Class II | 21 CFR 870.4220 | 52 | 267 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | Class II | 21 CFR 870.4240 | 91 | 35 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | Class II | 21 CFR 870.4420 | 9 | 11 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | Class II | 21 CFR 870.4340 | 17 | 15 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | Class II | 21 CFR 870.4300 | 10 | 0 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | Class II | 21 CFR 870.4410 | 8 | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | Class II | 21 CFR 870.4350 | 255 | 107 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | Class II | 21 CFR 870.4380 | 37 | 12 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | Class II | 21 CFR 870.4370 | 21 | 2 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | Class II | 21 CFR 870.4250 | 30 | 52 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | Class II | 21 CFR 870.4430 | 15 | 0 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | Class II | 21 CFR 870.4390 | 21 | 48 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | 21 CFR 870.4210 | 401 | 563 |
| DWG | Electrosurgical Device | Class II | 21 CFR 878.4400 | 4 | 0 |
| DWH | Blade, Saw, Surgical, Cardiovascular | Class I | 21 CFR 878.4820 | 4 | 1 |
| DWI | Saw, Electrically Powered | Class I | 21 CFR 878.4820 | 2 | 0 |
| DWJ | System, Thermal Regulating | Class II | 21 CFR 870.5900 | 161 | 70 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | Class II | 21 CFR 880.5780 | 64 | 4 |
| DWM | Apparatus, Suction, Patient Care | Class II | 21 CFR 870.5050 | 19 | 3 |
| DWO | Needle, Biopsy, Cardiovascular | Class I | 21 CFR 878.4800 | 11 | 9 |
| DWP | Dilator, Vessel, Surgical | Class II | 21 CFR 870.4475 | 20 | 1 |
| DWQ | Stripper, Vein, External | Class II | 21 CFR 870.4885 | 8 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | Class I | 21 CFR 870.4500 | 71 | 20 |
| DWX | Stripper, Artery, Intraluminal | Class II | 21 CFR 870.4875 | 14 | 0 |
| DWZ | Device, Biopsy, Endomyocardial | Class II | 21 CFR 870.4075 | 23 | 1 |
| DXC | Clamp, Vascular | Class II | 21 CFR 870.4450 | 205 | 26 |
| DXE | Catheter, Embolectomy | Class II | 21 CFR 870.5150 | 74 | 57 |
| DXF | Catheter, Septostomy | Class II | 21 CFR 870.5175 | 21 | 10 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Class II | 21 CFR 870.1435 | 177 | 8 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | Class II | 21 CFR 870.2920 | 297 | 10 |
| DXJ | Display, Cathode-Ray Tube, Medical | Class II | 21 CFR 870.2450 | 78 | 21 |
| DXK | Echocardiograph | Class II | 21 CFR 870.2330 | 78 | 0 |
