FDA 510(k) database integration

FDA 510(k) database integration

March 30, 2021

We are excited to announced that ResoluteAI's Foundation now offers the FDA's 510(k) Premarket Notification in its database. The 510(k) dataset is the seventh FDA dataset to be included. The others are: Medical device enhancement, Medical device recalls, FAERS, Drug product labeling, MAUDE, and Orange book. 

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What is the 510(k) database?

Submitting a 510(k) to the FDA is the most common way for organizations to launch medical devices to market. Organizations bringing devices to market or doing research on existing devices use the 510(k) database. Companies submit a 510(k) to demonstrate that:

  1. Their device is safe and effective
  2. The intended use of the device is similar enough to an existing (predicate) device, indicating that the new device does not need to go through a pre-market approval process

The new device can, however, vary in technological characteristics.

Why research the 510(k) database within ResoluteAI's research platform?

  • Search the 510(k) database simultaneously with other integrated FDA databases
  • Target research through specific search categories and tags
  • Apply analytics to database data
  • Export searches and data visualizations
  • Set up alerts directly to inbox


Want to learn more? Get in touch below!

Let's talk

Eléonore Dixon-Roche

Eléonore Dixon-Roche, our senior product manager, grew up in Norway and the UK and speaks English, French, and Spanish. You can reach Eléonore at eleonore@resolute.ai.