Start with the exact device name, model, manufacturer and any FDA submission number. Search the FDA database that matches the stated pathway, then compare the returned record with the product and intended use.
Check a device against the FDA record for the exact model and manufacturer. The FDA directs consumers to Devices@FDA for cleared and approved products, and to separate searches for De Novo records and 510(k) information.
FDA status lookup checklist
- Record the product’s exact name, model or version, and legal manufacturer.
- Copy any FDA identifier from the product page or labeling, such as a 510(k) or PMA number.
- Search Devices@FDA by product or company name.
- If the page states a De Novo route, search the FDA De Novo database.
- If it states a 510(k), use the FDA’s searchable 510(k) information.
- Compare the record’s device name, company and intended use with the exact product claim.
- Keep the pathway wording from the FDA record: cleared, classified or approved.
The FDA says establishment registration and device listing do not establish that a specific device was cleared, approved or authorized. Read FDA registration, clearance and approval terms before interpreting a product page.
For questions about what a device’s readings mean for you, speak with your doctor.
Sources
Common questions
Where can I search FDA device records?
The FDA links consumers to Devices@FDA, the De Novo database and searchable 510(k) information.
What information should I use in a search?
Use the device name, company name and the submission number shown in the product or FDA record.
Does a company registration number prove a device is cleared?
No. FDA establishment registration and device listing do not denote clearance, approval or authorization.
What if the product page does not identify a record?
Ask the manufacturer for the exact regulatory pathway and record identifier, then compare it with the FDA's current database.