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    510(k) Summary vs 510(k) Statement

    Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    Definition

    Every 510(k) submission must include either a 510(k) Summary or a 510(k) Statement. A 510(k) Summary describes the safety and effectiveness information FDA reviewed and is posted publicly on the FDA 510(k) Premarket Notification database after clearance, it is the document competitors and customers read to understand a cleared device. A 510(k) Statement is a certification by the submitter that, upon request, they will provide safety and effectiveness information described in the submission to any person within 30 days. Most submitters file Summaries; Statements are used when the submitter prefers not to publish a summary upfront but is willing to respond to individual requests.
    What the regulation says
    21 CFR 807.92 (510(k) Summary content requirements) and 21 CFR 807.93 (510(k) Statement requirements). FDA's 510(k) database hosts every Summary; Statements appear in the database as a noted designation only.

    What this means in practice

    Choice of Summary vs Statement has competitive and commercial implications. A well-written 510(k) Summary serves as marketing collateral, it's often the first technical document a hospital or competitor sees. A Statement provides less public visibility but creates an obligation to fulfill information requests within 30 days, which most companies underestimate. For high-profile or controversial products, the choice is often strategic.
    Common pitfalls
    • •Filing a Summary that is too thin, FDA expects substantial detail about indications, technological characteristics, performance testing, and substantial equivalence rationale.
    • •Filing a Statement and then being unable to respond to information requests within 30 days, failure constitutes a violation.
    • •Treating the Summary as confidential, it is public the day clearance is issued.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-06-20
    eCFR·2FDA·1
    1. 1
      21 CFR 807.92 - 510(k) Summary
      Verified
      eCFRecfr.gov
    2. 2
      21 CFR 807.93 - 510(k) Statement
      Verified
      eCFRecfr.gov
    3. 3
      FDA - Medical Devices
      Bot-blocked
      FDAfda.gov

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