Skip to main content

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)

:::⚠️ Important: A device approved via PMA cannot serve as a predicate for a 510(k). Only devices cleared through 510(k), preamendments devices, or devices classified via De Novo order are valid predicates. PMA-approved devices are in a separate regulatory class (Class III) and follow the PMA supplement pathway for modifications, not the 510(k) pathway. Only devices cleared through 510(k), preamendments devices, or devices classified via De Novo order are valid predicates. :::

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​