All terms
RegulatoryRegulated Pathways
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 the regulation says
The FDA, under 21 CFR 807.92(a)(3), requires a medical device manufacturer to identify a predicate device that is legally marketed in the United States when submitting a 510(k) Premarket Notification. The new device must be substantially equivalent to the predicate in terms of intended use, technology, and safety and effectiveness. The EU MDR does not use the term "predicate device" but has analogous provisions for demonstrating conformity, often through comparison to similar devices already on the market.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.Examples
- A company developing a new surgical Stapler identifies an older model of surgical stapler from a different manufacturer that already has 510(k) clearance, using it as a predicate.
- A manufacturer of a novel diagnostic imaging system uses a previously cleared MRI machine as a predicate, demonstrating similar intended use and fundamental scientific technology.
- A startup creating an AI-powered diagnostic software lists a cleared, non-AI diagnostic software with the same intended use as its predicate to establish substantial equivalence in basic function, then addresses the AI-specific aspects.
Common pitfalls
- •Choosing a predicate device with different indications for use than the new device can lead to a finding of "Not Substantially Equivalent."
- •Selecting a predicate that has been recalled or has known safety issues can jeopardize the 510(k) submission.
- •Failing to adequately document the similarities and differences between the new device and the predicate can result in submission delays or rejection.
- •Relying on a predicate device for which there is insufficient publicly available information can make substantial equivalence difficult to prove.
- •Not considering the technological characteristics and performance data of the predicate can lead to an inappropriate comparison.
Frequently asked questions
A device is legally marketed if it was in commercial distribution before May 28, 1976 (preamendments device), or has been reclassified from Class III to Class II or I, or has been found substantially equivalent through the 510(k) process, or has been approved through a PMA or granted through a De Novo classification request.
Cross-references
Related terms
Shared paths + categoryRegulatory
Substantial Equivalence(SE)
The legal standard a 510(k) device must meet versus a predicate.
510(k) Fundamentals · adjacentDe Novo & Breakthrough Pathways · adjacent
Regulatory
510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
510(k) Fundamentals · adjacentDe Novo & Breakthrough Pathways · adjacent
Regulatory
De Novo Classification Request(De Novo)
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
510(k) FundamentalsDe Novo & Breakthrough Pathways
Regulatory
Indications for Use(IFU (statement))
Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.
510(k) Fundamentals · adjacentDe Novo & Breakthrough Pathways · adjacent
Regulatory
Intended Use
The objective intent of the manufacturer regarding the use of the device.
510(k) FundamentalsDe Novo & Breakthrough Pathways
Regulatory
Breakthrough Device Designation(BDD)
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
De Novo & Breakthrough Pathways
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·2European Commission·1
- 1Best Practices for Selecting a Predicate DeviceVerifiedFDAfda.gov
- 2FDA - Medical DevicesVerifiedFDAfda.gov
- 3European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.