510(k) Submissions

510(k)s (Pre-market notifications) are the most commonly filed marketing authorizations for medical devices and IVDs.

510(k)s are utilized for moderate-risk devices, classified as US Class II. The submission must include technical and scientific documentation that demonstrates the new device is substantially equivalent to a legally marketed device, known as the predicate device. In some cases, clinical data may also be included.

Choosing the right predicate device is a crucial aspect of the regulatory strategy and plays a significant role in the application's success.

Multiple device-specific requirements exist, and navigating performance standards and guidance documents is essential to successful submission.

Let us help you with your 510(k)!