Written and maintained by CASRAI Editorial Board
Last updated
Short answer: The FDA Product Classification Database is the CDRH-developed list of medical device names, each with its classification, product code, premarket review organization and related regulatory information. Searching it tells you which generic device category a product falls under and how that category is regulated. It does not tell you that a specific brand is cleared or approved. This guide is general product information, not medical or regulatory advice.
Definition and scope
The FDA describes the database as “a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information.” The device names and associated information are developed by the Center for Devices and Radiological Health (CDRH). The FDA states that the name and product code together identify the generic category of a device for the agency, and that the product code is assigned based on the device’s classification under the regulations in 21 CFR Parts 862 to 892.
Devices regulated by the Center for Biologics Evaluation and Research are handled separately under intercenter agreements, so a biologics-related product may not be found here the way a typical device is.
How to search it
The FDA’s own guidance on determining whether a product is a medical device lists three ways to find a classification: search the Product Classification Database, search similar devices in the PMA, 510(k), De Novo and HDE databases, or review a legally marketed device’s listing in the Establishment Registration and Device Listing database. The first is the usual starting point.
Quick search and advanced search
Quick Search takes keywords. The FDA advises trying several, including singular and plural forms (the page gives singular and plural forms of a term as an example). Advanced Search narrows by product code, regulation number or device class.
Reading the search fields: which field answers which question
The search form exposes the fields below. The right-hand column describes what each field is useful for, going by the field names and the FDA’s description of the database.
| Search field (as labelled by the FDA) | Values the form offers | Question it helps with |
|---|---|---|
| Device | Device name keyword | What generic category does this product belong to? |
| Product Code | Product code | What other entries share this category? |
| Review Panel | Review panel | Which specialty group reviews this category? |
| Regulation Number | CFR regulation number | Which regulation defines the device type? |
| Device Class | Unclassified, I, II, III, HDE Not Classified | What risk-based class applies to the category? |
| Submission Type | 510(k), PMA, Contact ODE, 510(K) Exempt, HDE, Enforcement Discretion, EUA | Which premarket route, or exemption, applies to the category? |
| Third Party Eligible | Y / N | Is the category flagged as eligible for third-party review? |
| Implanted Device | Y / N | Is the category flagged as implanted? |
| Life-Sustain/Support Device | Y / N | Is the category flagged as life-sustaining or life-supporting? |
| Summary Malfunction Reporting | Eligible / Ineligible | Is the category eligible for summary malfunction reporting? |
The database next to the other FDA device databases
Each FDA database answers a different question. The rows below follow the FDA’s classification guidance.
| Source | What it answers |
|---|---|
| Product Classification Database | Whether an existing classification applies to a product, found by keyword, product code, regulation number or device class. |
| PMA, 510(k), De Novo and HDE databases | The public FDA decisions that permit marketing authorization for similar devices. |
| Establishment Registration and Device Listing database | The device listing of a legally marketed device, which shows how that device is classified. |
For the registration side, see our guide to the FDA registration and listing database. For the decision databases, see the guides to FDA 510(k) data and the PMA database, the 510(k) vs PMA comparison, and the dictionary entry on De Novo classification.
Where it matters for labs, clinics and supply decisions
The FDA states that most Class III (high risk) devices require Premarket Approval, and most Class II (moderate risk) devices require 510(k) clearance. A product’s entry therefore points to the usual premarket route for its category. The Submission Type field also lists “510(K) Exempt” as a value, which is how exempt categories are recorded.
A lookup starts from a plain device name and leads to a product code, a regulation number and, where the category is exempt, a Submission Type of “510(K) Exempt”. For background on what counts as a device in the first place, see what is a medical device.
Common misunderstandings
A classification is not an approval
The database identifies the generic category of a device. A class or product code describes the category and its regulatory route; it is not a statement that a particular manufacturer’s product has been cleared or approved.
Absence from the databases is not illegality
The FDA notes that most Class I and some Class II devices may not appear in the premarket databases because they are exempt and do not require FDA review before marketing. A missing 510(k) record can therefore be normal for an exempt category.
Different copies refresh on different schedules
The FDA’s product code page states that its downloadable product code files are updated every Sunday (that page shows a content date of 03/22/2018). The search form itself showed a last-updated date of 10/26/2026 when checked on 2026-10-30. The openFDA copy is derived from the same database, converted to JSON, and is updated monthly. openFDA also carries the disclaimer not to rely on it for decisions regarding medical care.
FAQ
What is the FDA product classification database?
It is the FDA’s searchable list of medical devices with their classifications, product codes, premarket review organizations and related regulatory information, developed by CDRH.
How do I find a device’s classification?
Use Quick Search with several keywords, or Advanced Search by product code, regulation number or device class. The FDA also suggests checking the PMA, 510(k), De Novo and HDE databases and the device listing of a similar legally marketed device.
Does a product code mean the FDA approved a product?
No. The name and product code identify the generic category of a device for the FDA.
Sources
- FDA, Product Classification database search form, page last updated 10/26/2026, checked 2026-10-30.
- FDA, How to determine if your product is a medical device, checked 2026-10-30.
- FDA, Product Code Classification Database, content current as of 03/22/2018, checked 2026-10-30.
- openFDA, Device classification and Product classification dataset, checked 2026-10-30.
