510(k) submission checklist


Going through a 510(k) submission? Understand each step you'll need to take with our comprehensive process checklist.

Instant access. No email required.


Download our 510(k) submission checklist to:

  • Know what you need to do (and when!) during your 510(k) submission process

  • Tick off each step as you go to ensure nothing is missed

  • Plan a confident and right-first-time roadmap to FDA clearance




What you'll get:


  • Check-bgStep-by-step checklist 

Follow a logical, step-by-step submission pathway from finding a predicate to assembling the correct documentation


  • Subttasks-bgSubmission sections

Understand how to group your submission documents and how the pieces of your submission fit together


  • Clock-bgFast and right-first-time clearance

Ensure nothing's overlooked, missed or improperly completed with our end-to-end process map