510(k) Clearances (original) (raw)

Overview of Section 510(k)

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or indications for use.

Browse and Search for 510(k) Clearances

Search the 510(k) Premarket Notification database.

Browse for Clearances by Year

• 510(k) Devices Cleared in 2023 (Archived)
• 510(k) Devices Cleared in 2022 (Archived)
• 510(k) Devices Cleared in 2021 (Archived)
• 510(k) Devices Cleared in 2020 (Archived)
• 510(k) Devices Cleared in 2019 (Archived)
• 510(k) Devices Cleared in 2018 (Archived)
• 510(k) Devices Cleared in 2017 (Archived)
• 510(k) Devices Cleared in 2016 (Archived)
• 510(k) Devices Cleared in 2015 (Archived)
• 510(k) Devices Cleared in 2014 (Archived)
• 510(k) Devices Cleared in 2013 (Archived)

Search the 510(k) Premarket Notification database.

You can also download zipped 510(k) files for specific time periods.

General Information

• Medical Device Safety and the 510(k) Clearance Process
• Total Product Life Cycle for Medical Devices
• Premarket Notification 510(k)
• Safety and Performance Based Pathway

Guidances for Industry and FDA

• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
• Safety and Performance Based Pathway
• The Special 510(k) Program
• The Abbreviated 510(k) Program
• Refuse to Accept Policy for 510(k)s
• Deciding When to Submit a 510(k) for a Change to an Existing Device
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device