510(k) Clearance
An FDA regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. 510(k) clearance is required before marketing most Class II medical devices in the United States.
A 510(k) is a premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device (the predicate device). Most Class II medical devices require 510(k) clearance before they can be sold in the US market.
Key concepts
- K-number: Every cleared 510(k) receives a unique identifier (e.g., K212345)
- Predicate device: The legally marketed device your product is claimed to be equivalent to
- Substantial equivalence: Same intended use and either same technological characteristics or different characteristics that don't raise new safety/effectiveness questions
- Indications for Use: The specific clinical applications the device is cleared for
510(k) in tender compliance
When a hospital tender requires FDA clearance, procurement teams verify the K-number against the FDA database, check that the Indications for Use cover the tender's clinical application, and confirm the clearance hasn't been superseded or withdrawn.