Leírás

FDA 510(k) Database

What do you need to know about the database?

The FDA 510(k) Database is a valuable resource for accessing information about medical devices cleared for marketing in the United States. Managed by the U.S. Food and Drug Administration (FDA), it provides public access to records of devices that have gone through the 510(k) premarket notification process.

Database Administrator

U.S. Food & Drug Administration

What data are included in the database?

The FDA 510(k) Database includes key information such as:

1. 510(k) Number: A unique identifier assigned to each device submission.
2. Device Name: The name of the medical device submitted to the FDA.
3. Applicant Name: The manufacturer or company that submitted the 510(k) notification.
4. Decision Date: The date the FDA issued its decision regarding the device's clearance.
5. Regulation Number: The classification regulation under which the device falls.
6. Product Code: An FDA code identifying the general device category.
7. Decision: FDA's determination (e.g., "cleared," "approved," "not substantially equivalent").
8. Review Panel: The medical specialty relevant to the device (e.g., cardiology, orthopedics).
9. Predicate Device: The legally marketed device to which the new device claims substantial equivalence.

How to search the database?

To search the FDA 510(k) Database:

1. Visit the FDA 510(k) Database.
2. Use search criteria such as 510(k) number, device name, applicant name, decision date, product code, or review panel.
3. Apply filters to refine search results.
4. Click on specific results to view detailed regulatory information about a device.

For related databases, visit RELATED DATABASES.