FDA product code lookup in the device classification database
An FDA product code identifies a generic device category. Find the three-letter code and read its class, regulation number and submission type.
For a medical device, an FDA product code is a three-letter identifier for a generic category. Find a candidate in the FDA classification database using part of the device name, compare that category with the intended use and indications, and read its class, regulation number and submission type. The code names a category, not one device's clearance or approval. The FDA product code classification database says the name and product code identify the generic category, based on the classification designated under 21 CFR Parts 862-892. FDA's classification page calls that identifier a three-letter product code.
FDA uses the same "product code" label for imports, which is easy to mix up. That code has five to seven numbers and letters. The FDA product code builder is the import tool, not another way to find this three-letter classification code. FDA's example is 79L--RR, First Aid Kit including drugs. Medical devices in that import format have no subclass and no process indicator, so those positions are hyphens. The import class letter is not regulatory Class I, II or III.
How to search the FDA product code database
FDA's classification page gives two methods. Search the FDA device classification database for part of the device name. If you know the medical-specialty panel, find the device there and identify its regulation. Classification depends on the intended use of the device and also on indications for use. A similar name is not enough.
In the classification-file documentation, device names usually start with a noun, then one or more adjectives. The first word is usually the best search term. FDA's example is pump. For each candidate:
- Compare the category name and definition with the intended use and indications.
- Open the classification regulation and read the device definition.
- Read the class and the submission-type designation separately.
- If the category is exempt, read the applicable exemption limitations.
If the definition does not fit the intended use, do not choose the code from the name alone. Keep looking.
For an FDA product code list, use the database or FDA's downloadable classification files. The download page explains the fields when you read a record outside the search page.
What an FDA product code search returns
| Field | What it tells you |
|---|---|
| Product code | The generic device-category identifier |
| Device class | The level of CDRH regulation |
| Regulation number | The classification regulation that contains the device definition |
| Submission type | The category's submission designation, separate from class |
Those meanings come from FDA's download dictionary. openFDA's field documentation maps submission type 1 to 510(K) and 4 to 510(K) Exempt. Don't read the submission designation off the class. The dictionary also lists a GMP exemption flag separately, and that flag is not a 510(k) exemption.
Worked example using product code PZW
The official openFDA record for PZW shows how to read one category. The retrieved dataset was last updated on October 19, 2026.
| Field | PZW record |
|---|---|
| Device name | Catheter Access Cover, Tamper-Resistant |
| Device class | 2 |
| Regulation number | 880.5970 |
| Submission type | 1, meaning 510(K) |
The definition is a tamper resistant catheter access cover intended to control unauthorized access to a central venous catheter. Match that intended use before you treat PZW as a candidate. The 1 to 510(K) mapping is on FDA's field documentation.
Then read 21 CFR 880.5970. It classifies the device as Class II with special controls, and it names guidance on premarket notification submissions for short-term and long-term intravascular catheters. The section has no exemption provision.
PZW shows how to read the fields. It is not a classification for your device, and the category record does not prove an individual clearance or approval. Check the current record before you decide. The dated API snapshot cannot show changes after October 19, 2026.
Check the limits of a 510(k) exemption
An exempt label still has limits. FDA says every device classified as exempt is subject to the limitations in 21 CFR xxx.9, where xxx refers to Parts 862-892. Read the regulation that applies before you rely on the label. FDA's classification page points there.
21 CFR 880.9 is the Part 880 version. It limits an exemption to existing or reasonably foreseeable characteristics of commercially distributed devices of that generic type. It still requires a premarket notification when, among other cases, the intended use differs from a legally marketed device in that type, or the device uses a different fundamental scientific technology. It does not grant PZW an exemption, and it is not the limitation section for every part.
Device listing uses the same code
The same three-letter product code is the classification number on the Medical Device Listing form. FDA's example is FLK, Clinical Mercury Thermometer. Listing is still a separate task from this category lookup. See FDA's classification page.
RegAffairs AI answers this product-code question with links to its cited sources.