These lists include cleared 510(k) submissions for which we have supporting documents available, and reflects the information as of the clearance date. They are not updated with regard to applicant or application status change.

Cleared 510(k) Submissions with Supporting Documents

• Cleared 510(k) Submissions with Supporting Documents - 2022
• Cleared 510(k) Submissions with Supporting Documents - 2021
• Cleared 510(k) Submissions with Supporting Documents - 2020
• Cleared 510(k) Submissions with Supporting Documents - 2019
• Cleared 510(k) Submissions with Supporting Documents - 2018
• Cleared 510(k) Submissions with Supporting Documents - 2017
• Cleared 510(k) Submissions with Supporting Documents - 2016 - ARCHIVED
• Cleared 510(k) Submissions with Supporting Documents older than 2016 - ARCHIVED
• Revised 510(k) Documents from Archived Content

Resources For You

• Substantially Equivalent 510(k) Device Information
• 510(k) Blood Establishment Computer Software
• 510(k) Process (CBER)