What is the FDA 510(k) database?

It is FDA's public, searchable list of premarket notification (510(k)) decisions, hosted on accessdata.fda.gov. Each entry shows the 510(k) number, applicant, device name, product code, regulation, dates and decision, with a link to the summary or statement when FDA has posted one.

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

Type the full number, a K followed by six digits, into the 510(k) Number box on FDA's search page and press Search. The record page opens directly. Numbers that start with DEN are De Novo requests and live in FDA's separate De Novo database.

Why can't I find a device in the 510(k) database?

Common reasons: the device is exempt from 510(k); it was authorized through De Novo or PMA, which have their own databases; it is filed under the applicant's legal name rather than the brand; or the decision is newer than the data you are searching. Tools built on openFDA lag FDA's website by days to weeks.

What does SESE mean on a 510(k) record?

SESE is FDA's decision code for "substantially equivalent". The search form lists other decision codes too, such as SESU (substantially equivalent with limitations) and SESK (substantially equivalent, kit).

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

A summary is a public document describing the device, its predicate and the testing behind the submission. A statement is a certification under 21 CFR 807.93 that the submitter will provide the submission's safety and effectiveness information within 30 days of a written request.

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

Yes. openFDA's device 510(k) endpoint (api.fda.gov/device/510k.json) returns the same core fields as JSON and also carries De Novo numbers. Our database uses it; its data currently runs through Oct 26, 2026.

How to search the FDA 510(k) database and read a record

A field-by-field guide to FDA's 510(k) Premarket Notification database, the De Novo and PMA databases next to it, and the openFDA API.

Updated 2026-11-09 · Sources: FDA and openFDA, linked below

FDA's 510(k) database is at accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. If you have a number such as K250507, type it in the 510(k) Number box and search. If you don't, search by Applicant Name or Device Name, then use the three-letter Product Code to find every device of the same type.

For PPG, pulse oximeter and wearable devices you can also filter our FDA database of 459 records by company, product code, year and Rx/OTC, and share the filtered link.

Which database to search

FDA device databases
Database	Numbers	Use it for
510(k) Premarket Notification	K + six digits	Cleared devices: most Class II and some Class I and III
De Novo	DEN + six digits	New device types granted without a predicate
Premarket Approval (PMA)	P + six digits	Approved Class III devices

If you are not sure which pathway applies, read FDA cleared vs approved first. FDA also offers downloadable 510(k) files for bulk work.

The search fields

The form fields, in the order FDA shows them:

FDA 510(k) search form fields
Field	What to enter	Tip
510(k) Number	The full number, for example K250507	Fastest route. It opens the record directly.
Type	Traditional, Special or Abbreviated	Special 510(k)s are usually changes to the company's own device.
Product Code	Three letters, for example DQA or QDB	The best way to list every device of one type.
Applicant Name	Part of the company's legal name	Search a short distinctive word. Suffixes and typos vary.
Device Name	Part of the name on the submission	This is the submitted name, which can differ from the retail name.
Panel	The review panel, for example Cardiovascular	Useful with a date range to scan a specialty.
Decision	For example SUBST EQUIV (SESE)	Leave blank to see every decision.
Decision Date	A from and to date	Combine with a product code to see what is new.
Third Party Reviewed, Clinical Trials, Predetermined Change Control Plan Authorized	Check boxes	Narrow a result list once it is already small.
Sort by	Decision date, device name, applicant or 510(k) number	Decision date (descending) puts the newest first.

Applicant names are the legal entity on the submission, written the way the company filed them. FDA's records, for example, list the same pulse oximeter maker as both "Beijing Choice Electronic Technology" and "Beijing Choice Electronic Technololgy". A search for "Beijing Choice" finds both.

Reading a 510(k) record

Opening a number shows one record page. Here is what each line means, using K250507, Apple, Inc.'s Hypertension Notification Feature (HTNF), as the example.

Fields on an FDA 510(k) record page
Field on FDA's page	Meaning	K250507
Device Classification Name	FDA's name for the device type behind the product code	Hypertension Machine Learning-Based Notification Software
510(k) Number	The submission number	K250507
Device Name	The name on the submission	Hypertension Notification Feature (HTNF)
Applicant	The company that submitted it, with its address	Apple, Inc.
Regulation Number	The 21 CFR section that classifies this device type	870.2380
Classification Product Code	Three-letter code for the device type	SFR
Date Received / Decision Date	When FDA received the submission and when it decided	Feb 21, 2025 / Sep 11, 2025
Decision	The outcome, with its code	Substantially Equivalent (SESE)
Summary / Statement	Link to the 510(k) summary PDF, or a 510(k) statement	Summary PDF
Type	Traditional, Special or Abbreviated	Traditional
Reviewed by Third Party	Whether an FDA-recognized third party did the review	Shown on FDA's page
Predetermined Change Control Plan Authorized	Whether FDA authorized a plan for specified future changes	Shown on FDA's page

The record page does not list the predicate or the full indications for use. Those are in the summary PDF: the indications usually appear on an "Indications for Use" page, and the summary names the predicate device and compares it with the new one. A 510(k) statement replaces the summary with a certification, under 21 CFR 807.93, that the submitter will provide the information within 30 days of a written request.

Search by product code

The product code is the most reliable way to find comparable devices, because it reflects how FDA classified the device instead of what the company calls it. Codes that matter for PPG and wearables:

Product codes for PPG and wearable devices
Code	FDA name	Records in our database
DQA	Oximeter	151
QDB	Photoplethysmograph Analysis Software For Over-The-Counter Use	5
QDA	Electrocardiograph Software For Over-The-Counter Use	9
SFR	Hypertension Machine Learning-Based Notification Software	1
QZW	Over-The-Counter Device To Assess Risk Of Sleep Apnea	3

The full list of codes we cover, with FDA's definitions, is on the FDA database page.

Search with the openFDA API

For repeatable lookups, the openFDA device 510(k) endpoint returns JSON with fields such as k_number, applicant, device_name, product_code, date_received, decision_date and decision_code. A single record:

https://api.fda.gov/device/510k.json?search=k_number:K250507

Every record under one product code, newest first:

https://api.fda.gov/device/510k.json?search=product_code:QDB&sort=decision_date:desc&limit=100

The endpoint also carries De Novo (DEN) numbers. It does not include predicates, indications or Rx/OTC status, which come only from the PDFs. openFDA updates roughly weekly and lags FDA's website, so a brand-new decision may show on accessdata.fda.gov before it reaches the API.

Common mistakes

Searching by brand. The applicant is a legal entity, and one brand can file under more than one name.
Treating one clearance as covering every feature. Each software feature on a watch can have its own number.
Looking for a De Novo in 510(k) results. Use the De Novo database or search the DEN number.
Reading "cleared" as "approved". They are different FDA decisions; see cleared vs approved.
Assuming no record means a device is sold illegally. Many devices are exempt from 510(k).

A filtered view for PPG and wearable devices

Our FDA database pulls the PPG, pulse oximetry, wearable ECG, blood pressure, sleep and monitoring records into one table, with filters FDA's form doesn't have: claim, sensor type and Rx/OTC. Some starting points:

Every row links to its FDA record. Indications, predicates and Rx/OTC there are parsed from FDA PDFs and labelled that way, so check the PDF before you quote them.

Questions

What is the FDA 510(k) database?: It is FDA's public, searchable list of premarket notification (510(k)) decisions, hosted on accessdata.fda.gov. Each entry shows the 510(k) number, applicant, device name, product code, regulation, dates and decision, with a link to the summary or statement when FDA has posted one.
How do I look up a 510(k) number?: Type the full number, a K followed by six digits, into the 510(k) Number box on FDA's search page and press Search. The record page opens directly. Numbers that start with DEN are De Novo requests and live in FDA's separate De Novo database.
Why can't I find a device in the 510(k) database?: Common reasons: the device is exempt from 510(k); it was authorized through De Novo or PMA, which have their own databases; it is filed under the applicant's legal name rather than the brand; or the decision is newer than the data you are searching. Tools built on openFDA lag FDA's website by days to weeks.
What does SESE mean on a 510(k) record?: SESE is FDA's decision code for "substantially equivalent". The search form lists other decision codes too, such as SESU (substantially equivalent with limitations) and SESK (substantially equivalent, kit).
What is the difference between a 510(k) summary and a 510(k) statement?: A summary is a public document describing the device, its predicate and the testing behind the submission. A statement is a certification under 21 CFR 807.93 that the submitter will provide the submission's safety and effectiveness information within 30 days of a written request.
Is there an API for the 510(k) database?: Yes. openFDA's device 510(k) endpoint (api.fda.gov/device/510k.json) returns the same core fields as JSON and also carries De Novo numbers. Our database uses it; its data currently runs through Oct 26, 2026.