What is FDA 510k?

An FDA 510k is a pre-marketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective that is substantially equivalent to a legally sold device that is not subject to premarket approval PMA

510 k premarket notification to FDA is required at least 90 days before marketing unless the device is exempt from 510 k requirements.

Here are the 510k four phases below.

1. Know your product code.

If you do not know your product code, click on the product code list, and get your product code.

2. Once you know your product code, you need to understand how your medical device is classified and your product's 510 k requirements.

Does your device require 510k Submission to FDA, or as your device exempt from 510 k submission?

We made it simple and easy for you. Enter the product code and check your device class regulation and 510 k requirements.

3. If your device required 510 k premarket notification to FDA, get your product 510 k total product lifecycle reports.
4. Take a look at the sample reports.

The sample reports give you valuable information regarding your product device class device regulation details, review panel details, GMP exempt details, all manufacturers and their device submission related to the product code, and FDA decision letter 510 K.

The FDA decision letter contains predicate device details device description, intended use, and substantially equivalent comparison.

Now you have all the required information. Prepare 510k Submission

If you want to learn more about the FDA 510k submission process, visit our website page. 510k Submission and guidance.

Thank you for reading.