Traditional 510k

Traditional 510 k


The Traditional 510 k is one among the three types of the 510 k in the US FDA. This type of 510k can be used for any circumstances and any kind of medical devices for which the premarket notification is applicable for the marketing in the USA. Traditional 510 k should contain the explanations on the intended use, technological characteristics, reports on the performance tests and demonstration of the substantial equivalence with the predicate device.


The contents of the Traditional 510 k contain some common sections. These sections include some forms from the FDA such as FDA 3601, FDA 3514, FDA 3881. Apart from these the contents include the indication of use, 510 k summary, Declaration of Conformity, Device description, Executive summary, Substantial equivalence, Labelling, Bio compatibility testing protocol and reports, sterilization details, Electric Safety reports, Performance Testing protocol and reports.


Is all the above sections to be on the sequence and what if one of section is not applicable?
What is a 510k summary generally contains?