A 510(k) is a premarket submission to the FDA that demonstrates your medical device is “substantially equivalent” to a legally marketed device already on the market (called a “predicate”). This pathway is typically used for low- to moderate-risk Class II devices.
There are two types of 510(k) submissions:
- Substantially Equivalent (SE) without a clinical study: Your device is essentially the same as the predicate in terms of intended use, technology, and performance. No new clinical data is needed.
- Substantially Equivalent (SE) with a clinical study: Your device has some differences from the predicate—such as new materials, modified indications, or updated design—that may affect safety or effectiveness. In this case, a clinical study (usually under an Investigational Device Exemption, or IDE) is required to support the submission.
Use the 510(k) pathway when a predicate device exists and your product does not introduce major changes in use, function, or risk profile.
