Find a Predicate Device

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In a 510(k) submission, applicants must demonstrate that a new device is substantially equivalent to a legally marketed device. A claim of substantial equivalence does not mean the devices must be identical, but they must have equivalent intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics.

The device to which equivalence is drawn is known as the predicate device.

A predicate device must:

• have been legally marketed prior to May 28, 1976 (preamendments device), or
• be a legally marketed device which has been reclassified from Class III to Class II or I, or
• be a legally marketed device which has been found to be substantially equivalent to such a device through the 510(k) process.

To find a predicate for your medical device, you can search the 510(k) database. The most useful ways to search the database are by using the applicant name, the product name, or the procode for the type of device you are seeking.

For more information about finding a predicate device, see Device Advice.

Find a Predicate Device Now