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    510(k) Premarket Notification

    FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a device to be marketed is at least as safe and effective - that is, substantially equivalent - to a legally marketed device that is not subject to premarket approval (PMA).
    What the regulation says
    FDA reviewers look for clear side-by-side comparisons to the predicate, complete performance testing, and - when applicable - premarket cybersecurity documentation per Section 524B.

    What this means in practice

    Most Class II devices in the United States reach the market through the 510(k) pathway. A clearance (often called 'K number') is required before commercial distribution. Choice of predicate, indications for use, and performance testing are central to a successful submission.

    Examples

    • A new infusion pump cleared as substantially equivalent to an existing pump.
    • A connected patient monitor citing a predicate plus added cybersecurity controls.

    Use cases

    2 scenarios
    1

    Updated patient monitor with a new pulse oximetry module

    Regulatory Affairs lead

    A Class II patient monitor manufacturer adds a third-party SpO₂ module. They identify their previous-generation monitor as the predicate, document substantial equivalence in technological characteristics, and provide bench performance data per ISO 80601-2-61.

    OutcomeFDA clears the device in ~5 months, allowing the new module to ship under the existing brand without a full PMA.
    2

    Software-only SaMD diagnostic algorithm

    SaMD product manager

    A startup files a 510(k) for an ECG analysis SaMD, citing a cleared algorithm as predicate. They submit IEC 62304 software documentation, performance testing on a held-out clinical dataset, and a cybersecurity package addressing FDA's 524B requirements.

    OutcomeCleared as a Class II SaMD; the team can begin commercial pilots with hospital systems.
    Common pitfalls
    • •Treating 510(k) clearance as 'FDA approval' - it is a clearance based on equivalence, not an approval.
    • •Choosing a predicate with materially different indications, technology, or performance.
    • •Underestimating cybersecurity content now expected for software-containing devices.

    Cross-references

    Governed by

    Regulations or standards this term must comply with.

    Uses

    Concepts or artefacts this term builds on.

    Contains

    Sub-elements or required artefacts of this term.

    Precedes

    Comes before in a typical workflow or lifecycle.

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1eCFR·1RAPS·1
    1. 1
      510(k) Premarket Notification
      Verified
      FDAfda.gov
    2. 2
      21 CFR Part 807 Subpart E
      Verified
      eCFRecfr.gov
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

    Inline markers like [1] jump to the matching reference above.