FDA 510(k) Database

Definition

The FDA 510(k) database is FDA’s public, searchable record of premarket notification — 510(k) — submissions and their outcomes. For every cleared device it lists the device name, applicant, 510(k) number, product code, decision, and decision date, and it is updated weekly. Anyone can use it to find predicate devices, research competitors, or confirm whether a device has been cleared.

Medical device companies who wish to sell their products in the United States must obtain FDA authorization through one of several regulatory pathways, including clearance via 510(k), approval via PMA, or a De Novo classification. For some devices, this means participating in the Premarket Approval (PMA) process, a scientific review conducted by the FDA to determine the safety and effectiveness of a class III medical device. 

Medical device manufacturers that are introducing a new product to the market, or have substantially modified an existing device in order to create a new one must complete a 510(k) premarket submission to the FDA. The FDA maintains a database of premarket notification 510(k) submissions on its official website, enabling users to search for existing submissions using criteria such as the 510(k) number, applicant, device name or FDA product code.

FREE DOWNLOAD: Click here to download a PDF of our 510(k) submission checklist.

What is an FDA 510(k) submission?

The 510(k) submission process provides an avenue for medical device companies to obtain clearance to market their devices in the United States. Rather than going through the lengthy scientific review associated with the premarket approval process, medical device manufacturers can undertake a 510(k) submission to demonstrate that their product is substantially equivalent to other legally marketed devices and that it may therefore be legally marketed. Devices reviewed through this pathway are “cleared,” not “approved”; approval is the term for the PMA pathway.

A medical device company that wishes to market a class I, class II or class III medical device in the United States, and for which a premarket approval (PMA) is not required, must submit a 510(k) premarket notification to FDA unless the device qualifies for an exemption from the requirements of the Federal Food, Drug and Cosmetic Act. 

How to access the FDA 510(k) Database

The FDA’s database of 510(k) premarket notifications is available for public access on the department’s official website. Users can search through the FDA’s historical database of 510(k) notification documents, including applications for some of the most recent innovations in medical device technology by the world’s largest medical technology companies.

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device. The database is updated weekly with newly reviewed 510(k) notifications.

To access a broad sampling of 510(k) notifications, users can use broad search terms like “pump” or “heart”. The database search tool also allows users to search for categories of medical devices based on the FDA panel that evaluated them. For medical device developers, this offers an easy way to gain insight into what new innovations may become popular in your field of expertise. Simply highlight the dropdown menu labeled “Panel” and choose to see search results for medical devices used in Toxicology, Gastroenterology, Cardiology, or another specialization of your choice.

How to search the FDA 510(k) database, step by step

1.  Go to FDA’s 510(k) Premarket Notification database on fda.gov (Devices@FDA search).

2. Search by device name, applicant, 510(k) number (“K” number), or product code.

3. Use the Panel dropdown to browse by review specialty — cardiovascular, toxicology, gastroenterology, and so on.

4. Open a result to see the decision, decision date, regulation number, and, for many clearances, a link to the 510(k) summary PDF.

5. Use a cleared device’s product code to pull every other device cleared under that code, which is the fastest route to a predicate device list.
   

What information is searchable in the FDA 510(k) database?

When a user clicks on an individual search result in the FDA 510(k) database, they will be presented with additional information pertaining to the 510(k) notification paperwork that was filed for the device. These include:

• The device classification name
• 510(k) number
• The name of the device
• The name of the applicant which filed the 510(k)
• Contact information for the applicant
• An assigned classification product code that indicates the type of medical device
• The date that the 510(k) notification was received and the date that a decision was made
• The substantial equivalence decision result (whether the 510(k) notification successfully demonstrated substantial equivalence between the new medical device and a predicate device)
• Any specific FDA regulations that apply to that medical device
• Identification of the 510(k) review panel that reviewed the notification for the device

In addition to these data points, the FDA may provide a link to the original 510(k) notification documents that were submitted. These documents are useful as a template for what a successful 510(k) application might look like when coupled with a safe and effective medical device

Related FDA databases

The 510(k) database only covers premarket notifications. Related searches live elsewhere: the PMA database (Class III approvals), the De Novo database (novel low-to-moderate-risk devices), the Product Classification database (find your product code and device class), GUDID (unique device identifiers), and MAUDE (adverse event reports).

Greenlight Guru helps streamline the 510(k) submission process

When it comes to obtaining 510(k) clearance, Greenlight Guru helps medical device manufacturers avoid some of the most common 510(k) pitfalls and mistakes that can stall or delay the process.

Greenlight Guru's eQMS software helps medical device companies ensure quality throughout the product design and development process. Designed exclusively for the medical device industry, the cloud-based platform becomes the single source of truth for the secure storage and management of all documentation related to a manufacturer’s 510(k) submission.

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