The US FDA's medical device classification system in the United States of America predominantly depends on a predicate system for classifying medical devices. That is, drawing comparisons to legally marketed devices and determining the classification of I, II, or III based on the risk. To enable manufacturers, to determine the classification of their devices or to search for Substantially Equivalent (SE) of their devices, FDA provides a Medical Device classification database. In cases where the SE is not found, manufacturers can explore alternative options by submitting an FDA 513(g) Submission to obtain the agency's recommendations on the device's classification and applicable regulatory requirements. The FDA 513(g) request serves as a valuable tool for manufacturers seeking clarity and guidance on the regulatory pathway for their medical devices.