FDA 510(k) Glossary · regulatory

Product Code

A product code is a 3-character alphanumeric code assigned by the FDA to group medical devices that share the same intended use, technological characteristics, and regulatory requirements. Each 510(k) submission is assigned a product code that determines which FDA review panel evaluates it and which device class and special controls apply.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
4,615 product codes represented in the dataset across 20 FDA review panels. QIH (AI radiology software) is among the fastest-growing codes in recent years.

Definition

An FDA product code is a 3-character alphanumeric classification code assigned to medical devices that share the same intended use, technological characteristics, and applicable regulations. Product codes appear in every 510(k) submission and determine the regulatory framework - including device class, applicable special controls, and which of the 20 FDA review panels evaluates the submission.

Structure and Assignment

Product codes correspond to specific entries in the FDA's device classification database and are linked to regulations in Title 21 of the Code of Federal Regulations (CFR). Each product code is associated with:

  • A device name and definition
  • A device class (I, II, or III)
  • A CFR regulation number (e.g., 21 CFR 880.3710)
  • The applicable FDA review panel
  • Applicable special controls (for Class II devices)

Dataset Insights

MetricValue
Total product codes in dataset4,615
Product codes with enriched intro text339
Largest panel by product codesCardiovascular
Fastest-growing product codeQIH (AI radiology software)

Finding a Product Code

Browse all product codes in the 510k Database by device classification. Each product code page shows submission history, average review times, leading manufacturers, and trend data.

FDA References

Related Terms

Review Panel - Device Class - 510(k) Premarket Notification - Predicate Device

Frequently Asked Questions

An FDA product code is a 3-character alphanumeric identifier (e.g., QIH, GEX, IYO) that classifies a medical device based on its intended use and technological characteristics. It determines the applicable device class, special controls, and which FDA review panel evaluates the 510(k) submission. Each product code corresponds to a device classification regulation in the Code of Federal Regulations (CFR).

The FDA Product Classification Database at accessdata.fda.gov allows manufacturers to search by device name or regulation number to identify the applicable product code. Selecting the wrong product code is a common cause of 510(k) acceptance failures. Many manufacturers engage a regulatory consultant to confirm product code selection before submission.

The 510k Database tracks 4,615 product codes across 166,200 submissions. High-volume product codes include orthopedic and cardiovascular categories. QIH (AI-based radiology software) is among the fastest-growing product codes in recent years, reflecting the surge in AI medical device submissions.

A product code classifies the device type and applies to all devices in that category. A K-number (e.g., K243854) is the unique identifier for a single 510(k) submission. One product code covers thousands of submissions; one K-number identifies one specific submission by one manufacturer.