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.

Why we built this

The FDA's official 510(k) search tool at accessdata.fda.gov is functional but limited. It does not support full-text search, lacks filtering by review time or clearance rate, and provides no context around manufacturers or product categories. Regulatory professionals told us they were spending hours manually cross-referencing data that should be available in seconds.

510k Database was built to fix that. We index the same public FDA data but make it searchable, browsable, and contextually enriched with manufacturer profiles, product code classifications, monthly clearance analysis, and average review times by specialty. Everything is sourced from official FDA public files and updated automatically each month.

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

Device classification data is enriched via the openFDA Device Classification API, which adds product codes, FDA review panel assignments, device class (I, II or III), and applicable CFR regulation numbers to each record. Device descriptions are further enriched using AI-assisted summarization to provide human-readable context for each product code category.

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.

Extended device intelligence

Beyond the core FDA 510(k) data, each device record is progressively enriched with additional information retrieved directly from official public sources. This enrichment is applied to published devices and expanded over time.

Regulatory submission details

For each device, we retrieve additional fields from the FDA's official 510(k) record that are not included in the downloadable data files. These include the regulatory consultant (the firm that managed the submission on behalf of the applicant), flags for third-party review, combination product status, and whether a Predetermined Change Control Plan (PCCP) was authorized - a pathway increasingly relevant for AI and software-based medical devices.

Identifying the regulatory consultant behind a submission is particularly valuable for competitive intelligence: it reveals which consulting firms specialize in specific device categories and which companies they represent.

Linked clinical trials

When the FDA's 510(k) record references a registered clinical trial, we retrieve the corresponding study data from ClinicalTrials.gov via its public API. This links each device record to the clinical evidence submitted as part of its clearance pathway.

For each linked trial, we surface the study title, design, enrollment count, number of sites, condition studied, primary and secondary outcomes, timeline, and whether results have been published. A notable signal is when a study is listed as completed but has not posted results to ClinicalTrials.gov - a pattern common in industry-sponsored device trials where data is referenced in the 510(k) Summary PDF but not publicly disclosed.

Clinical trial data is cached and refreshed periodically. Not all devices have linked trials - this information is only displayed when explicitly referenced in the FDA's 510(k) record.

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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