FDA 510(k) Predicate Graph
Trace substantial-equivalence lineage: the predicate devices a 510(k) cites and the later devices that cite it. Search any device, then click nodes to walk the chain.
Search a device to see the predicate devices it was built on (its lineage, upstream).
Single-click a node for its details. Double-click a predicate to drill in and reveal its predicates.
In short: This page maps the FDA 510(k) predicate network: which cleared device was used as the predicate for which. It covers 76,670 devices and 107,132 predicate links, extracted from 510(k) summary documents. The FDA publishes the clearances but does not publish this lineage as a connected dataset.
What a predicate device is
Most devices reach the US market through a 510(k), by showing substantial equivalence to a legally marketed device called the predicate. Each clearance therefore points backwards to at least one earlier device, and those references form a chain that can run back decades.
Where this data comes from, and why it is not in openFDA
The openFDA 510(k) endpoint lists clearances but does not expose the predicate reference. The predicate is named in the 510(k) summary document, which is published as a PDF. This graph is built by parsing those summaries, which is why the lineage can be traced here and not through the API.
| Measure | Value |
|---|---|
| Devices in the graph | 76,670 |
| Predicate links between them | 107,132 |
| Source of the links | 510(k) summary documents |
| Source of the clearance records | openFDA 510(k) endpoint |
What you can use it for
Tracing a device's ancestry supports predicate selection for a new submission, shows how a technology has propagated across manufacturers, and helps identify where a long equivalence chain rests on an old device. It is a research aid for regulatory strategy, not a substitute for reading the underlying clearances.
Known limits
A predicate link exists here only where it could be read from a published summary. Some clearances have no summary available, some summaries name a predicate in a form that cannot be resolved to a K number, and a small number of references are ambiguous. Treat a missing link as unknown rather than as evidence that none exists.
Frequently asked questions
What is a predicate device?
The legally marketed device that a new 510(k) submission is compared against to show substantial equivalence.
Does the FDA publish this predicate network?
The FDA publishes the individual clearances and their summary documents. It does not publish the predicate relationships as a connected dataset, which is what this page provides.
How many devices does the graph cover?
It contains 76,670 devices connected by 107,132 predicate links.
Can a device have more than one predicate?
Yes. A submission may cite multiple predicates, and the graph records each reference it can resolve.
Why is a device I expected missing a predicate link?
The link is only recorded where it could be read from a published 510(k) summary. Where no summary is available or the reference cannot be resolved to a K number, no link is drawn.