FDA Clearance
Also known as: 510(k), 510k Clearance
The FDA's authorization for a medical device to be marketed in the US, granted through the 510(k) substantial equivalence pathway.
Full Definition
510(k) clearance is the most common FDA pathway for HealthTech innovations. It requires demonstrating substantial equivalence to a legally marketed predicate device. Clearance does not require proof of clinical superiority â only that the device is as safe and effective as the predicate. The 510(k) pathway typically takes 3â12 months and costs $50Kâ$500K depending on the device and the level of clinical data required.
Example
A surgical instrument company submits a 510(k) citing a cleared predicate device. After a 6-month review, FDA grants clearance. The company can now market in the US but still needs to establish reimbursement before economic buyers can pay for it.