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Short answer
FDA 510(k) data is the public record of premarket notifications that FDA has made releasable. FDA states that its 510(k) database is searchable by 510(k) number, applicant, device name or product code. The same records are also published as downloadable files and through the openFDA API, so the right route depends on whether you are checking one device or analysing many.
Definition and scope
A 510(k) is the premarket notification submitted to FDA for a medical device; the pathway itself is explained in FDA 510(k) premarket notification. The 510(k) database is the searchable record of the notifications FDA has released. It is one of several databases FDA lists on its Medical Device Databases page, and it answers a narrow question: what was submitted, by whom, for what product code, and how FDA decided. It does not describe how a device performs, and a database entry is not an endorsement of the device.
Search fields and decision codes
The 510(k) search form on accessdata.fda.gov offers these fields: 510K Number; Type (Traditional, Special, Abbreviated); Product Code; Center; Combination Products; Applicant Name; Cleared/Approved; In Vitro Products; Device Name; Panel; Third Party Reviewed; Decision; Clinical Trials; Decision Date (from and to); and Predetermined Change Control Plan Authorized. Results can be sorted by decision date, device name, applicant or 510(k) number. The Panel field lists 20 review panels, such as Cardiovascular, Microbiology and Clinical Chemistry.
FDA 510(k) search: decision codes
The Decision field uses codes. Those listed on the form are:
| Code | FDA label |
|---|---|
| SESE | SUBST EQUIV |
| SESK | SUBST EQUIV – KIT |
| SESD | SUBST EQUIV – WITH DRUG |
| SESP | SE – POSTMARKET SURV REQUIRED |
| SESU | SE – WITH LIMITATIONS |
| SN | SUBST EQUIV FOR SOME INDICATIONS |
| SI | SUBST EQUIV – MARKET AFTER INSP |
The form also lists SEKD (SUBST EQUIV – KIT WITH DRUGS) and the tracking-related codes ST (SE SUBJECT TO TRACKING REG) and PT. Substantial equivalence is the standard behind these decisions; see predicate devices and substantial equivalence. The comparison of Special, Abbreviated and Traditional 510(k) explains the Type field.
Web search, downloadable files or openFDA
FDA provides three routes to the same family of records. They differ in what FDA says about each.
| Route | What FDA states |
|---|---|
| Web search form | Search by the fields above. FDA’s Medical Device Databases page states that the 510(k) database is updated once a week. |
| Downloadable 510(k) files | Zipped files: PMNLSTMN.ZIP (most current month available), PMN96CUR.ZIP (1996 to current), PMN9195.ZIP (1991-1995), PMN8690.ZIP (1986-1990), PMN8185.ZIP (1981-1985) and PMN7680.ZIP (1976-1980). FDA says the files are replaced monthly, usually on the 5th. Each record is 272 characters long, and a file layout document explains the fields and some codes. |
| openFDA device 510(k) endpoint | Product details and original sponsors of premarket notification applications, with administrative and tracking information. FDA states it covers 1976 onward and is updated monthly, and it includes receipt and decision dates and openFDA special fields. |
openFDA carries an explicit warning: do not rely on openFDA to make decisions regarding medical care.
Other FDA medical device databases and what each answers
People searching for the “FDA medical device database” are often looking for a different record than a 510(k). FDA’s Medical Device Databases page describes them as follows.
| Database | What FDA says it holds |
|---|---|
| Premarket Notifications (510(k)) | Releasable 510(k) records searchable by number, applicant, device name or product code |
| Product Classification | Device names with three-letter product codes and device classes |
| Devices@FDA | Catalog of cleared and approved device information, covering 510(k)s and PMAs |
| De Novo | Classification orders (see FDA De Novo classification) |
| Premarket Approvals (PMA) | Premarket approval records, listed by FDA as a separate database from 510(k) |
| AccessGUDID | Devices with a unique device identifier (see UDI and GUDID submission) |
| Registration and Listing | Establishments and device listings |
| Recalls of Medical Devices | Recalls classified since November 1, 2002 |
| MAUDE | Adverse event reports, with voluntary reports back to June 1993 (see medical device reporting) |
| Total Product Life Cycle (TPLC) | Combines PMA, 510(k), adverse event and recall data by device name or product code |
FDA lists further resources on the same page, including Recognized Consensus Standards, CLIA, HDE and post-approval studies. It also notes that the MDR 1992-1996 and X-Ray Assembler Data files are no longer updated.
Checklist for verifying a clearance
For staff checking a device against the database, each step below follows from the fields and databases described above.
- Search by 510(k) number when a manufacturer or document quotes one. Use the Product Code field when you only have a device type; a worked example is in FDA-cleared sharps containers.
- Read the Decision code against FDA’s labels in the table above rather than treating every entry alike. SESK marks a kit and SESU marks substantial equivalence with limitations.
- Check the Type, Decision Date and Applicant Name fields to match the entry to the product you are reviewing.
- Use TPLC or the Recalls and MAUDE databases when the question is about adverse events or recalls, which the 510(k) database does not hold.
- Confirm what the device is under FDA’s definition; see what is a medical device.
Common misunderstandings
Clearance is not approval
FDA describes Devices@FDA as “a catalog of cleared and approved medical device information”. Clearance refers to the 510(k) pathway and approval to PMA. A 510(k) decision is a substantial equivalence finding, not a PMA approval.
A database entry is not an endorsement
The database records a notification and FDA’s decision on it. It does not rank devices or state that one is better than another.
One database does not answer every question
Adverse events, recalls, device identifiers and establishment listings sit in separate FDA databases, as the table above shows.
FAQ
How do I do an FDA 510k search?
Use the 510(k) search form on accessdata.fda.gov and enter a 510(k) number, product code, device name or applicant name. Decision Date and Panel narrow the results, and Quick Search runs the query.
What is the FDA 510k database?
It is FDA’s searchable collection of releasable 510(k) premarket notification records, listed on the Medical Device Databases page. The same records are available as monthly downloadable files and through openFDA.
What is the FDA medical device database?
FDA does not have a single one. Its Medical Device Databases page lists several, including 510(k), Product Classification, Devices@FDA, PMA, De Novo, AccessGUDID, Registration and Listing, Recalls, MAUDE and TPLC. Pick the one that matches your question using the table above.
Sources
- FDA, Medical Device Databases, checked 2026-10-29.
- FDA, Premarket Notification 510(k) database search, checked 2026-10-29.
- FDA, Downloadable 510(k) Files, checked 2026-10-29.
- FDA, openFDA device 510(k) API, checked 2026-10-29.
