All terms

Predicate Device

A legally marketed device used as the comparator in a 510(k) submission.

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

Definition

A predicate device is a legally marketed device to which a new device is compared in a 510(k) Premarket Notification to support a determination of substantial equivalence.

What this means in practice

Selecting an appropriate predicate is one of the most consequential decisions in a 510(k). An ill-chosen predicate can trigger a Not Substantially Equivalent (NSE) determination, requiring a De Novo or PMA pathway.

Cross-references

Used by

Things that build on this term.

510(k) Premarket Notification(510(k))

Primary references

3 sources

Link health: 3 verified· last checked 2026-05-09

FDA·2European Commission·1

1

Best Practices for Selecting a Predicate Device
Verified

FDAfda.gov
2

FDA - Medical Devices
Verified

FDAfda.gov
3

European Commission - Medical Devices
Verified

European Commissionhealth.ec.europa.eu

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