BeanStock Ventures is a FDA-Recognized 510(k) Third Party Review Organization which means we can review select 510(k) device submissions on behalf of the FDA. This program saves you time and money by allowing you to clear your devices faster than the typical FDA processing time can be up to six months.

The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations (3P510(k) Review Organizations) such as BeanStock Ventures are allowed to review select medical devices while still maintaining FDA oversight.

View product website