Pre-market Notification 510K

The purpose of the 510k is to establish safety and efficacy of the new device by proving its substantial equivalence to a predicate device. The predicate device can be a pre-amendment device (devices prior to May 28, 1976 Medical Devices Amendment) or a post-amendment device that is substantially equivalent (with respect to intended use, component materials, etc.,) to a pre-amendment device. If substantial equivalence is established then the new device is subjected to the same regulations as the device to which substantial equivalence has been established. The comparison with the predicate device should include similarities/differences, identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.

In addition, all 510k submissions also require to state:
device name - proprietary and common name
device classification
device description
its intended use
proposed label, labeling, advertisements, directions of use
sterilization techniques
results of biocompatibility testing

Once submitted, the FDA takes 90 days to process the 510k and it can permit or deny the marketing of the device.