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Blog: Did you know? Navigator for Medical Devices has made 65,000 510(k) PDFs searchable by intended use, indications for use, and device description


What is a 510(k)?

In order to market a medical device, manufacturers must comply with the 510(k) section of the Food, Drug and Cosmetic Act.* This requirement states that device manufacturers must register and notify the FDA minimally 90 days in advance of their intent to market a medical device. Known as Premarket Notification – also called PMN or 510(k), this step signifies that a determination must be made to qualify the device as equivalent to a device already placed into Class I, II or III categories. For devices that are intended to be first-time market entrants for commercial distribution or devices that have undergone significant changes or modifications, a Premarket Notification is required. Any changes related to intended use, design, materials, chemical composition, process for manufacturing or source of energy; basically anything that could impact safety requires PMN. See more from the FDA about 510(k) Clearances here.

*Note: A medical device may qualify for a 510(k) exemption, e.g., most Class III devices where a Premarket Approval (PMA) is required instead of a 510(k) and most Class I devices.

How to achieve better regulatory intelligence and 510(k) prep when searching for FDA clearances?

The answer to 510(k) Research – Reed Tech Navigator™ for Medical Devices was created to aid in the 510(k) process and has made over 65,000 510(k) PDFs searchable by intended use, indications for use, and device description.

Navigator is a one-of-a-kind solution, designed to aid in 510(k) research by:

  • Enabling quick research for clearances with similar intended uses or indications for use
  • Finding new predicates for a specific or similar device in just a few clicks
  • Quickly sort and filter results by decision date within the Past 5 or 10 years
  • Provides full 510(k) details including FDA Product Codes, decision timeline, and supporting guidance documents
  • View Predicates and applicable Successors to existing Clearances
  • For ongoing monitoring, 510(k)s may be added to a Watchlist for event notifications
  • 510(k) search includes Biologic 510(k)s and De Novos in a single search

Reed Tech Navigator for Medical Devices and 510(k) search

Navigator for Medical Devices is a quick and comprehensive way to conduct searches for FDA Clearances and view 510(k) Predicates and Successors. Contact us for a customized demonstration and see how efficiencies are gained with Navigator. Thank you for providing contact details in the brief form below.

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