May 15, 2009
The FDA 510(k) database contains all devices cleared under the 510(k) process. The FDA databases on the web are updated on or around the 5th of every month. The classification of the device and product code is essential in searching for predicate devices. Classification of your device can be found by performing a search on the Product Code Classification Database.
Information which can be useful to find a predicate device includes:
- names of similar devices – traded name under which the device is marketed;
- manufacturer(s) of the similar device(s);
- marketing status, i.e., preamendments or postamendments device;
- 510(k) numbers for postamendments devices;
- classification information, i.e., product codes, classifying regulations, etc., for your device.
May 15, 2009
A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA). Submitters must compare their 510(k) device to a similar legally marketed U.S. device(s). A device recently cleared under 510(k) is usually used as a predicate device.
The legally marketed device(s) to which equivalence is drawn is known as the predicate device(s).
A claim of substantial equivalence does not mean the device(s) must be identical.Substantial equivalence is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. You can claim SE to either a preamendments or postamendments device that is or was legally marketed. Legally marketed means that the predicate cannot be one that is or was in violation of the Federal Food Drug & Cosmetic (FD&C) Act. An applicant may claim SE to a device that is no longer being marketed in the U.S.