Find your device’s FDA class and its usual path to market in about 30 seconds.
- Product code and classThe three-letter code FDA files your device under, and its risk class.
- Your likely pathway510(k), exempt, De Novo or PMA, and what that means for your plan.
- Links to check itFDA’s own record and the regulation for every code.
The short answer
FDA sorts every type of device into Class I, II or III by risk, and that class mostly decides your route to market. In FDA’s data, 2,155 of 2,403 Class I codes need no 510(k), 3,005 of 3,645 Class II codes list one, and 497 of 528 Class III codes list premarket approval (PMA).
How it works
- Describe your deviceUse the words a clinician would, such as “pulse oximeter” or “bone screw”.
- We search FDA’s listYour words are matched against the names and definitions of all 7,096 product codes.
- You get the closest codesEach one shows its class, the usual pathway and a link to FDA’s record.
Common devices and their FDA product codes
| Device | Product code | FDA device name | Class | Usual pathway | Regulation |
|---|---|---|---|---|---|
| Wearable ECG patch or Holter recorder | MWJ | Electrocardiograph, Ambulatory (Without Analysis) | II | 510(k) | 21 CFR 870.2800 |
| Over-the-counter ECG app that flags atrial fibrillation | QDA | Electrocardiograph Software For Over-The-Counter Use | II | 510(k) | 21 CFR 870.2345 |
| Pulse oximeter | DQA | Oximeter | II | 510(k) | 21 CFR 870.2700 |
| Home blood pressure monitor | DXN | System, Measurement, Blood-Pressure, Non-Invasive | II | 510(k) | 21 CFR 870.1130 |
| Continuous glucose monitor (integrated) | QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | II | 510(k) | 21 CFR 862.1355 |
| Insulin pump | LZG | Pump, Infusion, Insulin | II | 510(k) | 21 CFR 880.5725 |
| TENS unit for pain relief | GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | II | 510(k) | 21 CFR 882.5890 |
| Electronic stethoscope | DQD | Stethoscope, Electronic | II | 510(k) | 21 CFR 870.1875 |
| Manual stethoscope | LDE | Stethoscope, Manual | I | 510(k) exempt | 21 CFR 870.1875 |
| Over-the-counter hearing aid | QUF | Hearing Aid, Air-Conduction, Over The Counter | I | 510(k) exempt | 21 CFR 874.3300 |
| Bone fixation screw | HWC | Screw, Fixation, Bone | II | 510(k) | 21 CFR 888.3040 |
| Dental implant | DZE | Implant, Endosseous, Root-Form | II | 510(k) | 21 CFR 872.3640 |
| Robotic surgical system | NAY | System, Surgical, Computer Controlled Instrument | II | 510(k) | 21 CFR 876.1500 |
| Implantable pacemaker | DXY | Implantable Pacemaker Pulse-Generator | III | PMA | 21 CFR 870.3610 |
The check points you to likely codes; it does not decide your class. FDA does that, and you can ask it formally with a 513(g) request ($8,596 in FY2027, or $4,298 with an approved Small Business Determination). Products led by FDA’s drug or biologics center, such as many inhalers, show up here as “contact FDA”.
What OVA does here, and where our responsibility ends
We design the electronics, firmware and mechanics of medical devices and take them from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
The result is an orientation, not a regulatory opinion. Confirm the pathway with a regulatory specialist or through a Pre-Submission (Q-Sub) with FDA. The tool runs in your browser. Your answers are not sent to us; with your cookie consent, Google Analytics records only that the tool was used and the category of the result.
Questions
How do I find the FDA product code for my device?
Search with the clinical name and what the device measures or treats. The intended use and the technology decide the code, not the name. If you are unsure, ask FDA through a Pre-Submission or a 513(g) request.
Does Class II always mean a 510(k)?
No. In the October 21, 2026 data, 484 Class II product codes are exempt from a 510(k), within limits set in the regulation.
What if no product code fits my device?
Your device may be a new type with no legally marketed predicate; those often go through De Novo.
Is a product code the same as a regulation number?
No. One regulation in 21 CFR can cover several product codes with different classes: 21 CFR 870.1875 covers the manual stethoscope (Class I, exempt) and the electronic one (Class II, 510(k)).
Related pages
Sources
- openFDA: device classification endpoint, data as of October 21, 2026
- FDA: Product Classification database
- FDA: Classify Your Medical Device, content current as of August 26, 2026
- FDA: De Novo Classification Request
- eCFR: 21 CFR 870.9, limitations of exemptions from section 510(k); each device part has the same section
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2027, July 30, 2026
Data as of October 21, 2026. By Lisa Voronkova, CEO of OVA Solutions. Updated on October 22, 2026.