#Industry News
What is 510(k)？
The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act)
When the FDA receive the 510(k) submission, they will assign the submission a unique number which is commonly referred to 510(k) number, or K number followed by 6 digits.
For example, K210281
The first two digits 21 show the submission is received in 2021, the last four digits 0281 represent the submission number.
When is 510(k) required？
The 510(k) is required for medium-risk devices (most Class II as well as some Class I and III) that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the device. It’s not only required for new developed devices but also for devices that have been modified in a way that could impact safety or effectiveness. This could include changes to the:
Design
Components
Materials
Chemical composition
Energy source
Manufacturing process
Intended use
