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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.
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