: Summaries of safety and effectiveness for cleared devices are often available for download directly through the search results in the database. Common File Information
The FDA provides several ways to view and download this information securely:
: You can search for individual device clearances by manufacturer, device name, or 510(k) number using the Releasable 510(k) Database .
: These datasets include the device classification name, applicant contact information, product codes, and the date the clearance decision was made.
The term "510(k)" refers to a submitted to the FDA to demonstrate that a medical device is "substantially equivalent" to a legally marketed device in the U.S.. How to Access Authentic 510(k) Records