FDA 510(k) Glossary · submission

Predicate Device

Predicate device - a legally marketed medical device used as a reference in a 510(k) submission to demonstrate substantial equivalence. The FDA compares the new device's intended use and technological characteristics against the predicate to determine clearance eligibility.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
165,719 of 166,200 submissions (99.7%) cleared via predicate-based substantial equivalence. Largest predicate pools: Orthopedic (2,467), Radiology (2,043), Surgery (1,872).

Definition

Under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, a manufacturer seeking to market a new Class II medical device must demonstrate that it is substantially equivalent to a predicate device - a legally marketed device already on the U.S. market. The FDA does not require the new device to be identical to the predicate; it must share the same intended use and have technological characteristics that do not raise new questions of safety or effectiveness.

Valid Predicate Devices

  • Preamendment devices - devices commercially distributed in the United States before May 28, 1976, when the Medical Device Amendments were enacted.
  • Previously cleared 510(k) devices - any device that has received a Substantially Equivalent determination from the FDA.
  • De Novo classified devices - novel devices reclassified through the De Novo pathway, which can then serve as predicates for future 510(k) submissions.

Regulatory Context

Predicate selection is one of the most consequential strategic decisions in preparing a 510(k) submission. A poorly chosen predicate is a leading cause of Not Substantially Equivalent (NSE) determinations. The FDA evaluates substantial equivalence through a two-part test: first, whether the intended use is the same; second, whether technological differences raise new safety or effectiveness concerns.

Manufacturers may use multiple predicates simultaneously (a split predicate approach), citing one predicate for intended use and another for technological characteristics, though the FDA has signaled increasing scrutiny of this practice.

Predicate Device Use by FDA Panel

Predicate-based submissions are distributed across all 20 FDA panels. The following panels have the highest volume of published submissions in the 510k Database dataset - and therefore the deepest pool of available predicate devices:

PanelSubmissions
Orthopedic2,467
Radiology2,043
General & Plastic Surgery1,872
Cardiovascular1,416
General Hospital1,374

Search all published 510(k) clearances to find predicate devices by device name, product code, or manufacturer.

Predicate Chaining

Because a cleared 510(k) device can itself serve as a predicate, it is possible to construct chains of predicates extending back to pre-1976 devices. A 2021 study in PLOS ONE by Hwang et al. mapped the genealogy of FDA predicate chains and found that some devices rely on predicates with contested safety records. See Predicate Chain for a full analysis.

Dataset Insights

MetricValue
Total 510(k) submissions in dataset166,200
Clearances based on substantial equivalence165,719 (99.7%)
Not Substantially Equivalent determinations464 (0.28%)
Panels with highest NSE ratesMicrobiology (62), Neurology (54), Gastroenterology (47)
Largest predicate pool by panelOrthopedic (2,467 published), Radiology (2,043), Surgery (1,872)

Real Examples

  • K254066 - Etiometry Platform (Neurology, Special 510(k), 2026)
  • K243854 - Contour Light (Surgery, linked clinical trial, 2024)

Browse cleared devices by panel: Cardiovascular - Orthopedic - Radiology

FDA References

Related Terms

Substantial Equivalence - Predicate Chain - De Novo Classification - Not Substantially Equivalent - Third-Party Review

Frequently Asked Questions

A predicate device is a legally marketed medical device used as a reference in a 510(k) submission. The new device must demonstrate substantial equivalence - same intended use and no new safety or effectiveness concerns - to the predicate in order to receive FDA clearance.

Valid predicates include: (1) preamendment devices on the market before May 28, 1976; (2) devices previously cleared through a 510(k); and (3) devices granted De Novo classification, which establish new regulatory categories and can serve as predicates for future 510(k) submissions.

Predicate chaining occurs when a 510(k) submission uses a predicate that itself relied on an earlier predicate, creating a chain extending back to pre-1976 devices. Academic research has documented cases where these chains include predicates with contested safety records.

A recalled device is not automatically disqualified as a predicate, but the FDA scrutinizes predicate selection carefully. Using a recalled device as a predicate increases the risk of a Not Substantially Equivalent determination and is considered a significant strategic risk.