Ways to Search for a Predicate Device

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.

Source: FDA

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