How to search the FDA 510(k) database

A 510(k) is a premarket notification a company sends to the FDA before it sells a device in the US. When the FDA finds the device substantially equivalent to one already on the market, the device is cleared. You can look up any 510(k) in the FDA's free 510(k) database by K number, company name, device name or product code.

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This page shows how to search and read the FDA 510(k) database. To see which US device companies the FDA just cleared, go to new 510(k) clearances.

Last updated October 26, 2026. On that day, we checked each field name on this page against the FDA's live search form and a live 510(k) record.

What a 510(k) is, and why it is a clearance and not an approval

A 510(k) is a premarket notification. A company sends one to the FDA to show that its new device is substantially equivalent to a device already sold legally in the US. That older device is known as the predicate.

When the FDA agrees, the device is cleared. So the right word for a 510(k) is "cleared." The FDA approves a different kind of filing, the premarket approval (PMA). Source: the FDA page on Premarket Notification 510(k).

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

The FDA has two search pages. The simple search has one box. The advanced search has a box for each field. These steps use the advanced search.

Open the FDA 510(k) Premarket Notification database.
Pick one field to search. You can use the 510(k) number (the K number), the applicant (the company name), the device name or the product code.
Type what you know in that field.
If you want a date range, set the decision date.
Choose how to sort the results. You can sort by decision date, device name, applicant name or 510(k) number.
Press search and look at the list of results.
Click a 510(k) number to open the full record.

How to look up a 510(k) by K number

Type the number in the 510K Number box. A K number is the letter K and then six digits. Use this search when you already have the number, for example from a press release or a 510(k) summary.

How to look up a 510(k) by company

Type the company name in the applicant field. The same company can show up under more than one name. One record may say "Inc." and another may say "LLC." Some devices are filed under a parent company. Try a short form of the name, like the first word, so you catch every version.

The Applicant Name box holds up to 20 characters. That is one more reason to type a short form of the name.

How to search the 510(k) database by product code

A product code is a short FDA code made of letters. Devices of the same type share one product code, so this search shows 510(k)s for one type of device. If you do not know the code, click the Product Code label on the search form. That opens the FDA's Product Classification database, where you can look the code up.

How to search by device name

Type a word from the device name in the Device Name box. Each company picks its own device names. If a brand name finds nothing, try a plain word for the kind of device. This box also holds up to 20 characters.

How to search by decision date

Type a start date and an end date in the Decision Date boxes, or pick them from the calendar next to each box. You can add a date range to any other search. For example, a product code and a date range show the 510(k)s for one type of device in that time.

Other filters on the search form

You can also filter by type (Traditional, Special or Abbreviated), review panel, decision and FDA center. The form also has check boxes, such as Third Party Reviewed and Combination Products.

What each field on a 510(k) record means

Field	What it means
Device classification name	The FDA's name for the type of device.
510(k) number	The ID the FDA gives the filing. It starts with K, so people say "K number."
Device name	The name the company used for the device.
Applicant	The company that sent the 510(k).
Correspondent	The firm the FDA writes to about the 510(k). The FDA's cover sheet form says this can be a consultant, if it is not the applicant.
Applicant contact and correspondent contact	The person listed for the applicant and for the correspondent.
Regulation number	The part of federal rules that covers this type of device.
Classification product code	A short FDA code for the type of device. On the record, the code links to the FDA's classification page for that type of device.
Date received	The day the FDA got the 510(k).
Decision date	The day the FDA made its decision.
Decision	What the FDA decided, such as substantially equivalent (SESE). The search form lists other codes too, such as SESK for a kit.
Regulation medical specialty	The medical area that this type of device falls under in the rules.
510(k) review panel	The medical area that reviewed the device, like cardiovascular or orthopedic.
Summary or statement	A summary means the FDA has a 510(k) summary of safety and effectiveness for the device. A statement means you can ask the company for that information.
Type	The kind of 510(k). Traditional can be used for any 510(k). Special is for changes to a company's own device. Abbreviated relies on FDA guidance, special controls or recognized standards.
Reviewed by third party	Yes means an FDA-accredited review group looked at the 510(k) first. The FDA still makes the final decision.
Combination product	Yes means the device is combined with a drug or a biological product.
Predetermined change control plan authorized	Yes means the FDA also authorized a plan for certain future changes to the device.

Field names are as they appear on FDA 510(k) record pages. The meanings are our own plain words, not FDA definitions. They are based on these FDA pages: FDA, Search the Releasable 510(k) Database; FDA, 510(k) Submission Programs; FDA, 510(k) Third Party Review Program. The FDA also posts downloadable 510(k) files on its 510(k) Clearances page.

The 510(k) database vs openFDA

openFDA is the FDA's free API for the same 510(k) records. It is for people who write code. You can read about the openFDA device 510(k) API on open.fda.gov. Whimbrel pulls 510(k) clearances from openFDA. Each clearance in Whimbrel links back to the FDA record by K number. Read more about Whimbrel on the medtech MCP page.

The openFDA page says its 510(k) API covers records from 1976 on. The same page says openFDA updates the API monthly. That is openFDA's update schedule. The field names in openFDA are a little different. Some of them are k_number, applicant, device_name, product_code, decision_date, clearance_type and third_party_flag. See the openFDA searchable fields.

Where the 510(k) database falls short for sales research

The 510(k) database shows one kind of record. A 510(k) record does not tell you what else the company makes or what stage the company is at. The record does not show whether the company raised money or runs device trials. Recalls, inspections and warning letters live in other FDA databases. You also have to match name versions yourself. To get the full picture, you end up with many tabs open.

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Ask the same question in ChatGPT or Claude with Whimbrel

Whimbrel works inside ChatGPT or Claude. Type a question in plain words. Whimbrel answers with the company, the events on file, their dates and a link to each public source. Here are questions you can ask:

"Tell me about Varrowmede Surgical (Example). What FDA events does Whimbrel have on file?"

"Give me a rundown of [company name], including its 510(k) history."

"What's new in medtech? Any new 510(k) clearances?"

"Here is a list of companies from an FDA export. Put them in order for my firm."

"Where does Whimbrel's data come from?"

Example

The company: Varrowmede Surgical (Example), a US maker of surgical staplers on Whimbrel's list.

What is on file: The FDA cleared one of the company's devices through a 510(k). Whimbrel also has a funding filing on file for the company.

Sources: Each event shows its date and a link to the public record, like the FDA 510(k) database.

Made-up example company; the signal types are real.

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Pricing

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FAQ

What is the FDA 510(k) database?

The FDA 510(k) database is the FDA's free public list of 510(k) premarket notifications and the FDA's decisions on them. You can search the database on accessdata.fda.gov.

How do I do a 510k search?

Open the FDA 510(k) Premarket Notification page. Fill in one or more boxes, like applicant name, device name, product code or 510(k) number. Then press Search and open a record.

What is a 510(k)?

A 510(k) is a premarket notification a company sends to the FDA. The 510(k) shows that a new device is substantially equivalent to one already on the US market.

Is a 510(k) an FDA approval?

No. The FDA clears a device through a 510(k). The FDA approves PMA applications. The FDA also approves IDEs so a device can be used in a clinical study. See IDE approvals.

How do I look up a 510(k) by K number?

Type the number in the 510(k) number field of the FDA database. Then open the record.

How do I find every 510(k) for one company?

Search the applicant name. Try short forms of the name too, since one company can file under more than one name.

Can I search the 510(k) database by product code?

Yes. Type the product code in the Product Code box. If you do not know the code, look it up first in the FDA's Product Classification database.

Can I search the 510(k) database by decision date?

Yes. Type a start date and an end date in the Decision Date boxes. You can add a date range to any other search.

What does SESE mean on a 510(k)?

SESE is the decision code for "substantially equivalent." The FDA found the device substantially equivalent to its predicate, so the device is cleared.

What is the difference between a 510(k) summary and a 510(k) statement?

A summary means the FDA has a summary of safety and effectiveness information for the device. A statement means you can ask the company for that information.

What do Traditional, Special and Abbreviated mean on a 510(k)?

They are the kinds of 510(k). Traditional can be used for any 510(k). Special is for changes to a company's own device. Abbreviated relies on FDA guidance, special controls or recognized standards. Source: FDA, 510(k) Submission Programs.

What does "Reviewed by Third Party" mean?

Yes means an FDA-accredited review group looked at the 510(k) before the FDA. The FDA still makes the final decision. Source: FDA, 510(k) Third Party Review Program.

Is the FDA 510(k) database free?

Yes. Anyone can search the FDA 510(k) database for free, with no account.

Does the 510(k) database show recalls or warning letters?

No. Recalls and warning letters live in other FDA databases. See how to search FDA warning letters.

Is there an API for the 510(k) database?

Yes. openFDA offers a free device 510(k) API.

Is there a De Novo database too?

Yes. The FDA keeps a separate De Novo database. De Novo is the path for a new low to moderate risk device that has no predicate.

Where does Whimbrel's 510(k) data come from?

Whimbrel pulls 510(k) clearances from openFDA. Each clearance in Whimbrel links back to the FDA record by K number.

Which companies does Whimbrel cover?

Whimbrel covers US medical device companies and their suppliers.

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