Question 1

What is a predicate device?

Accepted Answer

A predicate device is a legally marketed medical device that a new 510(k) submission uses to demonstrate substantial equivalence. To clear a 510(k), you show FDA that your device has the same intended use and the same technological characteristics as the predicate (or that any differences do not raise new questions of safety and effectiveness). Choosing a strong, defensible predicate is one of the most important early decisions in a 510(k) strategy.

Question 2

How do I find a predicate device for my 510(k)?

Accepted Answer

Start from the FDA product code that matches your device's type and intended use. Every device cleared under that product code is a candidate predicate. In this tool, search by device name to find devices like yours, then click a product code to list every cleared 510(k) under it. Review the candidates for intended use, technology, and how recently they were cleared, then confirm the predicate is still legally marketed before relying on it.

Question 3

What is an FDA product code and why does it matter for predicates?

Accepted Answer

A product code is a three-letter classification FDA assigns to a device type, tied to a regulation number and device class. Devices that share a product code are the same regulatory device type, so the product code is the fastest way to assemble a candidate predicate pool. Filtering by product code in this tool returns the cleared devices most likely to qualify as predicates for a new submission of the same type.

Question 4

Is this FDA 510(k) database free to use?

Accepted Answer

Yes. The 510(k) predicate finder is free and requires no account. It searches the public FDA 510(k) clearance record so device and regulatory teams can scope predicates without a paid database subscription.

Question 5

Where does this 510(k) data come from?

Accepted Answer

The data comes from the openFDA 510(k) API, which mirrors FDA's public Premarket Notification 510(k) database. Each result links back to its authoritative record on FDA.gov so you can verify the clearance details, summary, and decision directly at the source.

Question 6

How current is the 510(k) clearance data?

Accepted Answer

openFDA refreshes its 510(k) dataset regularly (typically weekly). This tool queries openFDA live, so results reflect the latest data openFDA has published. For the most recent clearances or to confirm a specific record, follow the FDA.gov link on any result.

Question 7

Can a recently cleared device be used as a predicate?

Accepted Answer

There is no recency requirement for a predicate, but the predicate must be legally marketed and should not have been removed from the market for reasons of safety or effectiveness. Many teams prefer a more recent predicate because its technology and labeling are closer to current expectations, which can simplify the substantial-equivalence argument. Always confirm the predicate's current status before building a submission around it.

510(k) Predicate Database

Browse by device type

510(k) predicate & FDA 510(k) database FAQ