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Predicate Device Selection

Selecting the right predicate is one of the most consequential decisions in preparing a 510(k). A weak or inappropriate predicate can result in an NSE decision or a high volume of additional information requests.

What qualifies as a predicate?​

A valid predicate device is a device that was:

  1. Legally marketed before May 28, 1976 (the enactment date of the Medical Device Amendments), and has not been reclassified — known as a "preamendments device"; OR
  2. Cleared through the 510(k) process after May 28, 1976; OR
  3. Classified through a De Novo order (which creates a new legally marketed reference)
caution

A device approved via PMA cannot serve as a predicate for a 510(k).

Finding a predicate​

  1. 510(k) Database (accessdata.fda.gov) — search cleared devices by product code, device name, or applicant name
  2. FDA Product Classification Database — links cleared devices to their product code
  3. 510(k) Summary documents — publicly available summaries describe the predicate used and SE rationale

Predicate selection strategy​

A good predicate:

  • Has the same intended use as your device
  • Has closely similar technological characteristics
  • Is recently cleared (recent predicates reflect current regulatory standards)
  • Has a publicly available 510(k) summary allowing you to verify the basis of SE

Multiple predicates​

FDA permits the use of multiple predicates in a single 510(k):

  • Use Predicate A for intended use comparison
  • Use Predicate B for a specific technological characteristic

This is called a "split predicate" approach. FDA has accepted this strategy, though it requires clear and explicit justification in the submission.

The predicate chain​

A cleared 510(k) can itself serve as a predicate for a future 510(k), creating a predicate chain. While legal, long predicate chains can create problems:

  • Older predicates may no longer reflect current state of the art
  • FDA may raise concerns if a predicate chain leads back to a device with known safety issues

When no predicate exists​

If no suitable predicate exists, consider:

  • De Novo classification request — for novel, low-to-moderate risk devices
  • Expanding the predicate search to a higher-level device type (general intended use)
  • A Q-submission (pre-sub) to discuss predicate strategy with FDA before submitting

Official resources​