About 510k Database

What is 510k Database?

510k Database is a free, independent search tool for FDA 510(k) premarket notification records. It indexes 174,000+ device clearances from May 1976 to the present, sourced directly from the FDA's publicly available downloadable files.

The database is designed for regulatory affairs professionals, medical device manufacturers, healthcare procurement teams, researchers, and anyone who needs to quickly verify a device clearance, find a predicate device, or track competitor submissions.

510k Database is not affiliated with or endorsed by the FDA. It is an independent project built to make public FDA data easier to search and navigate. All underlying data is in the public domain under 17 U.S.C. § 105.

What is a 510(k) clearance?

A 510(k) is a premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device that was on the market before May 28, 1976, or to a device that has been subsequently cleared through the 510(k) process.

Most Class I and Class II medical devices sold in the United States require a 510(k) clearance before they can be marketed. The process typically takes 90 to 150 days. A cleared device (SESE) has been found substantially equivalent and may be marketed in the U.S. A not cleared decision (DENG) means the FDA determined the device is not substantially equivalent to any predicate.

For authoritative information about the 510(k) program, visit the FDA's 510(k) program page.

About the data

Source

All device records are sourced from the FDA 510(k) downloadable files, published monthly by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH). Device classification data is enriched via the openFDA Device Classification API.

Update frequency

The FDA publishes updated 510(k) records on the 5th of each month. This database syncs automatically within 24 hours of each FDA release. The database currently contains 174,402 records spanning from May 1976 to the present.

Coverage

The database includes all 510(k) submissions in the FDA's public files: cleared (SESE, SESK, SESU, SEKD, SESP, SESD), not cleared (DENG), and other decision types. Submissions are organized by 20 FDA review panels — from Anesthesiology to Toxicology — and 4,754 product code categories.

Limitations

This database reflects only what is available in the FDA's public 510(k) files. Some older records may have incomplete data. Device names, manufacturer names, and addresses are stored as submitted to the FDA and may contain variations or abbreviations. Always verify critical information directly at accessdata.fda.gov.

Who uses 510k Database?

Who is behind this project?

510k Database is developed and maintained by Space Bits, S.L., a technology company based in Manresa, Spain.

For data corrections, error reports, or general inquiries about the database, please contact us at hello@510kdatabase.net. We aim to respond within 5 business days.

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