How do you determine substantial equivalence for a 510(k) submission?


It is first important to identify the predicate device and its trade name, model number, 510(k) submitter, and 510(k) number. Additionally, the sponsor must provide a detailed comparison between the two devices in terms of:

  • Indications for use
  • Technology
  • Performance specifications, including any testing

Within the executive summary, it is also necessary to describe both the device in question and the predicate device in appropriate detail. Typically, a table is used to summarize and compare various characteristics of the two devices in appearance and functionality.

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About the Author
Proxima CRO Team
Dora Huang

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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