FDA 510(k) database
The 510(k) database is the public record of devices cleared for US marketing through premarket notification. It is the starting point for predicate research, competitive mapping and pathway feasibility.
What is the FDA 510(k) database?
It is FDA's public record of premarket notification submissions that have been cleared for marketing in the United States. Each entry lists the device name, applicant, decision date, product code, regulation number and decision type, and many entries link to a public 510(k) summary.
What does a 510(k) number look like and what does it mean?
A 510(k) number takes the form K followed by six digits, such as K231234. The first two digits indicate the year the submission was received, and the record it identifies is the specific clearance for one device from one applicant.
How do I find a predicate device?
Search the database by product code or by device name for cleared devices with a similar intended use and technology. Read their 510(k) summaries to see what evidence supported clearance, then judge whether your device is substantially equivalent in intended use and technological characteristics.
What does “substantially equivalent” mean?
It means your device has the same intended use as a legally marketed predicate and either the same technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness and are supported by data.
How often is the database updated?
FDA refreshes the device clearance data regularly, and the same records are available through the openFDA API. Recently cleared devices can take some time to appear, so treat the most recent weeks as incomplete.
Are 510(k) summaries free to access?
Yes. The clearance records and the published 510(k) summaries or statements are public and free on FDA's website and through the openFDA API.
Does clearance mean FDA approved my device?
No. Clearance under 510(k) means FDA found the device substantially equivalent to a predicate. Approval is a different, higher standard applied through the premarket approval pathway, generally for Class III devices.
Can I search the 510(k) database here?
Yes. The free 510(k) search tool on this site queries the public openFDA clearance data directly, and the free product code lookup helps you find the right code to search with.
Source: FDA device clearance records and the openFDA API. Confirm current requirements with FDA before relying on any record for a submission decision.
Choosing the best market for a medical device
Market selection is an evidence and payment question before it is a size question. These answers cover the decisions teams face most often.
What is the best market for a medical device?
The one where your existing evidence, a workable reimbursement pathway and your operating budget align. The United States is the largest single market and its evidence travels well, but it is not automatically the right first move for every device.
Should I always launch in the United States first?
No. Teams with clinical evidence aligned to EU expectations, European commercial partners, or a difficult US predicate situation often sequence differently. The decision should follow the factors, not a default.
When does Europe make more sense?
When your evidence already fits EU MDR expectations and your first customers are European. Plan around notified-body capacity, which is frequently the binding constraint on timeline.
How much does reimbursement change the answer?
A great deal. Authorization without a code, coverage and an actual payment amount produces no revenue. Treat reimbursement feasibility as a first-class factor rather than a post-clearance task.
What data should I compare across markets?
Regulatory route and timeline, whether your evidence is portable, reimbursement pathway, addressable volume, competitive intensity, clinical ecosystem, policy incentives, localization requirements, supply chain and operating cost.
How does MedTechCompass rank markets?
It starts from curated market baselines across ten dimensions, then applies a bounded device-specific adjustment that must cite retrieved evidence. Each score shows the baseline, the adjustment and its reason, and dimension weights are selected from your device profile with manual presets available as an override.
How many markets should I plan for?
Plan a sequence of three to five and execute one or two at a time, with explicit milestones that trigger the next entry.
Where to go next
Go deeper with MedTechCompass
Describe your device in plain language and get an AI-assisted triage: likely FDA class, product codes, premarket pathway, EU MDR and UK considerations — plus market attractiveness scoring across curated global markets.
This article is educational content from CAHIR Solutions and is not legal or regulatory advice. Regulatory decisions depend on your specific intended use and claims — confirm them with FDA resources, a qualified consultant, or a pre-submission meeting before filing.