FDA 510(k) Clearances

Data through 30 October 2026.

Records in the database

176,625

Newest decision

30 October 2026

openFDA last updated

2 November 2026

Decisions by year

2026 (to 30 October 2026)

2,830

2025

3,225

2024

3,129

2023

3,346

2022

3,209

2021

3,023

Most common product codes

GEX: Powered Laser Surgical Instrument Class II · 21 CFR 878.4810

2,895 clearances

GEI: Electrosurgical, Cutting & Coagulation & Accessories Class II · 21 CFR 878.4400

2,321 clearances

LLZ: System, Image Processing, Radiological Class II · 21 CFR 892.2050

2,297 clearances

LYY: Latex Patient Examination Glove Class I · 21 CFR 880.6250

1,954 clearances

DZE: Implant, Endosseous, Root-Form Class II · 21 CFR 872.3640

1,550 clearances

GCJ: Laparoscope, General & Plastic Surgery Class II · 21 CFR 876.1500

1,432 clearances

ESD: Hearing Aid, Air-Conduction, Prescription Class I · 21 CFR 874.3300

1,367 clearances

HRS: Plate, Fixation, Bone Class II · 21 CFR 888.3030

1,334 clearances

DXN: System, Measurement, Blood-Pressure, Non-Invasive Class II · 21 CFR 870.1130

1,227 clearances

IYN: System, Imaging, Pulsed Doppler, Ultrasonic Class II · 21 CFR 892.1550

1,189 clearances

Clearances by type

Traditional

157,218

Special

16,228

Abbreviated

2,604

Direct

382

Post-NSE

110

Dual Track

83

Source: the openFDA device 510(k) endpoint, read at build time and refreshed at most daily. Records are FDA's and unvalidated. The "Records" count includes De Novo grants, which carry DEN numbers.

The FDA 510(k) database is the public record of premarket notifications that ended in a clearance. A 510(k) is a submission that shows a device is as safe and effective as a legally marketed device, called the predicate (section 513(i)(1)(A) of the FD&C Act, 21 CFR 807.92). When FDA agrees, it sends an order letter that "clears" the device. A 510(k) device is cleared. Approval is the word for the separate PMA pathway.

Each record is one decision. It names the applicant, the device and the date FDA decided, and it carries the product code that places the device in FDA's classification system. The earliest record in the data was received on 21 June 1976, a month after the Medical Device Amendments took effect on 28 May 1976.

Two things set the boundary of the data. Every decision code in the openFDA dataset is a substantially equivalent variant or a De Novo grant. Submissions FDA found not substantially equivalent, and submissions the applicant withdrew, do not appear. And a submission still under review has no record yet.

De Novo grants sit in the same file under numbers that start with DEN instead of K. They are devices with no predicate that FDA classified into Class I or II. They look like 510(k)s in this dataset and are not.

This tool searches the openFDA copy of the data. FDA also runs its own Premarket Notification database, which is the same underlying records behind a different interface.

These are the fields the search returns, with what each one holds. openFDA documents the full set in its field reference.

K number

The submission number: K, then two digits for the year FDA received it, then four digits for the sequence. K253875 was received in 2025. De Novo grants use DEN in place of K.

Device name

The name the applicant gave the device, often a trade name. It is not a standard term, so search for the generic name and the brand.

Applicant

The company that submitted the 510(k), as it was written on the submission. The same company can appear under several names.

Date received

The day FDA received the submission.

Decision date

The day FDA issued its decision. The gap to the date received is the elapsed calendar time, including any hold while the applicant answered FDA's questions.

Decision

A code and a description. SESE is plain substantial equivalence. Other codes mark kits, drug combinations, limitations and postmarket requirements. See the next section.

Product code

Three letters that group devices with the same intended use and technology, for example FRN for infusion pumps. It is the key to finding predicates.

Clearance type

Traditional, Special or Abbreviated, which are the three 510(k) formats. Some records carry other labels, such as Direct (seen on De Novo grants), Dual Track or Post-NSE.

Advisory committee

The review panel specialty the product code falls under, such as Cardiovascular or Orthopedic.

Summary or statement

Summary means FDA publishes a 510(k) summary of safety and effectiveness. Statement means the applicant holds that information and must provide it on request. Older records leave it blank.

Third party flag

Y when a third party reviewed the submission instead of FDA staff.

Expedited review flag

Y when FDA granted the submission expedited review. It is rare.

Fill in one field or several. All the fields you fill in must match, and results come back newest decision first, 20 to a page. The address bar updates with each search, so any result can be shared as a link.

• By K number. Type the number with or without the K. This returns that one clearance. Try K890736, a Nihon Kohden infusion pump cleared in 1990.
• By device name.The words are matched as a phrase, in order. "infusion pump" finds names containing those two words together. Search the generic term first, then try brand names you know competitors use.
• By applicant. Use the short form of the company name, such as Medtronic, to catch every legal entity that begins with it. Add a device term to narrow a large applicant down.
• By product code. Enter three letters, or click the code on any result. This lists every clearance FDA has put under that code, which is the shortlist for a predicate. Try FRN.

If you do not know the product code for your device, find a competing device by name, read its code off the result, and search that. FDA's Product Classification database gives each code's device class and regulation number. The product code lookup shows the same fields with the Part 820 rules they point to.

More examples: infusion pump clearances, Medtronic clearances, radiological image processing (LLZ).

The decision code

Almost every record is SESE, which means substantially equivalent with nothing attached. The other codes in the data come from FDA's file layout for releasable 510(k)s:

• SESK and SEKD: substantially equivalent as a kit, and as a kit with drugs.
• SESD: substantially equivalent with a drug.
• SESU: substantially equivalent with limitations.
• SESP: substantially equivalent, with postmarket surveillance required.
• SN: substantially equivalent for some indications only.
• ST and PT: subject to tracking, and subject to tracking and postmarket surveillance.
• DENG: a De Novo request that FDA granted.

A code other than SESE is worth reading in the decision letter. It tells you FDA attached a condition to the clearance.

The clearance type

A Traditional 510(k) is the full format. A Special 510(k) covers a change to the applicant's own legally marketed device. An Abbreviated 510(k) leans on an FDA guidance document, a special control or a recognized standard. FDA explains each on its Premarket Notification 510(k) page.

The summary

Where the record says Summary, FDA publishes a 510(k) summary written under 21 CFR 807.92. For recent clearances it is a PDF at accessdata.fda.gov/cdrh_docs/pdf25/K253875.pdf, with the two-digit year of the K number in the folder name. It names the predicate, states the indications for use and lists the performance testing. Click any K number in the results to reach FDA's record for it.

Where the record says Statement, FDA holds no summary. Under 21 CFR 807.93 the applicant must supply the safety and effectiveness information within 30 days of a written request.

A 510(k) argues that your device is substantially equivalent to one already legally marketed. FDA's test is the same intended use, plus either the same technological characteristics or different ones that raise no different questions of safety and effectiveness. The predicate you pick sets the evidence you have to produce.

1. Get the product code. Search for the closest device by name and read its code.
2. List the code. Click the code to see every clearance under it. Start with the newest.
3. Open the summaries. Each Summary record names its own predicate and states its indications for use. Compare the indications wording to yours.
4. Follow the chain. A predicate has its own predicate. Walk back a step or two to see how the technology got to where it is.
5. Check the predicate's history.FDA says a predicate cannot be a device that violates the FD&C Act. Look for recalls and warning letters against it, with the recall search and the warning letter search.

FDA notes that any legally marketed device can serve as a predicate, although recent clearances are the usual choice. This tool cannot tell you whether a candidate is a good one. That depends on intended use wording, technological characteristics and how FDA has treated similar submissions. FDA's page on finding and using predicate devices covers the judgment calls.

• It lags. openFDA refreshes this dataset monthly, and FDA replaces its own download files monthly, usually on the 5th. A clearance from the last few weeks may be missing. The data block above shows the date of the newest decision.
• It lists decisions only. Pending submissions, withdrawals and not substantially equivalent findings are absent. 21 CFR 807.95 also lets an applicant ask FDA to keep the existence of a submission confidential for a period before the device is on the market.
• It does not list predicates. The predicate is in the summary PDF, not in a field you can search. Tracing a chain of predicates means reading documents.
• It does not show the review. Additional information requests, deficiency letters and test reports are not part of the public record unless they appear in the summary.
• It is unvalidated.openFDA says to treat records as unvalidated and not to rely on them for medical decisions. For a regulatory filing, confirm the record against FDA's own database.

You do not need this page to get at the data. Three routes exist.

FDA's web search. The Premarket Notification database searches by K number, applicant, device name or product code and links the summary PDFs.

The openFDA API. The endpoint is https://api.fda.gov/device/510k.json. A search for one clearance looks like ?search=k_number:"K253875", and a product code search looks like ?search=product_code:"FRN"&limit=100. Without a key, openFDA allows 240 requests a minute and 1,000 a day per IP address. A free key raises the daily limit to 120,000. Each request returns at most 1,000 records, and skip stops at 25,000, so deeper pulls use search_after. The query syntax is in the openFDA documentation.

Bulk files. openFDA publishes the endpoint as zipped JSON. FDA publishes fixed-width text files, one for 1996 to the present and older ones back to 1976.

What is the FDA 510(k) database?

It is FDA's public record of premarket notification submissions and their outcomes, covering clearances from 1976 onward. Each record shows the K number, device name, applicant, decision and date, and the product code assigned to the device.

What is a predicate device?

A legally marketed device you compare your own to in order to establish substantial equivalence. In practice a predicate is usually found among earlier clearances sharing the same product code and intended use.

How do I find a predicate device?

Search by device name to find comparable clearances, then use the product code on any result to list every other device cleared under that code. Narrowing by product code is the fastest route to a shortlist of candidates.

What is a product code?

A three-letter code FDA assigns to group devices with the same intended use and technology, such as FRN for infusion pumps. It is the most reliable field for finding comparable clearances.

Is this data official?

The results come directly from FDA's openFDA API, and every K number links to FDA's own detail page so you can verify it at source. FDA updates the dataset periodically, so very recent decisions may not appear immediately.

What does a K number mean?

It is the submission number FDA assigns to a 510(k): the letter K, two digits for the year FDA received the submission, then a four-digit sequence. K253875 was received in 2025. De Novo grants use DEN in place of K.

How often is the FDA 510(k) database updated?

openFDA refreshes the 510(k) dataset monthly, and FDA replaces its own download files monthly, usually on the 5th. Clearances from the last few weeks may not appear yet. This page shows the date of the newest decision in the data.

Is there an API or a bulk download for the 510(k) database?

Yes. The openFDA endpoint is api.fda.gov/device/510k.json, limited to 240 requests a minute and 1,000 a day per IP address without a free key. openFDA also publishes the dataset as zipped JSON, and FDA publishes fixed-width text files for 1976 to the present.

Does searching cost anything or require an account?

No. The search runs in your browser against FDA's public API. Nothing you type is sent to Arca or stored.

• What is GxP? (including how 21 CFR 820 became the QMSR in February 2026)
• Complete Response Letters: what happens when a submission is not approved
• FDA recall database: check whether a predicate has been recalled
• Regulatory glossary