The de Novo 510K process is classification procedure to classify the new medical devices which are not previously classified. The new rule has made the process easy by getting approval without the submission of 510K approval. An application is sent to the FDA, FDA evaluated the risk possessed by the device and classifies it into Class 1,2 or 3 medical device. Along with classification it establishes new regulation, necessary controls and product code. It can act as a predicate for a new medical device. The new rule is more efficient in releasing and marketing a novel device on time without delay (less time consumption).