Skip to main content

510(k)

Dashboard Overview​

The 510(k) module streamlines the premarket notification process by helping manufacturers demonstrate substantial equivalence to a legally marketed device.

510(k) Dashboard

Getting Started​

The submission process begins with properly identifying your device's regulatory classification.

Select Product Code​

The dashboard prompts you to define the device under review:

  • Search & Select: Use the "Select Product Code" dropdown to find the specific FDA product code that matches your device (e.g., OQW - 2009 H1N1 Influenza Virus...).
  • Classification: Selecting the correct code automatically retrieves associated regulation numbers, device classes, and submission requirements.