510(k) is a premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.
Complete Guide to 510(k)
A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. Named after Section 510(k) of the Federal Food, Drug, and Cosmetic Act, this pathway is the most common route to market for Class II medical devices in the United States.
Key requirements for 510(k) clearance:
- The device must have the same intended use as the predicate
- The device must have the same or similar technological characteristics
- If different, the submission must demonstrate equivalent safety and effectiveness
Types of 510(k) submissions:
1. Traditional 510(k) - Standard submission comparing to a predicate device
2. Abbreviated 510(k) - References FDA guidance documents or special controls
3. Special 510(k) - For modifications to your own cleared device
Average FDA review time: 90-180 days depending on complexity.
Most Class II devices require 510(k) clearance, while most Class I devices are exempt. Class III devices typically require the more rigorous Premarket Approval (PMA) pathway.
Related Terms
More Submission Types
View allA streamlined FDA 510(k) submission pathway that relies on FDA guidance documents, special controls, or recognized consensus standards to demonstrate substantial equivalence.
An FDA program designation for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
An FDA regulatory pathway for novel, low-to-moderate risk medical devices that have no predicate device for 510(k) comparison.
An FDA emergency authorization pathway that allows unapproved medical products to be used during public health emergencies when no adequate approved alternatives exist.
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