Frequently Asked Questions
What is FDA 510(k)?
FDA 510(k) is a premarket submission to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. It is the most common pathway for medical device clearance in the U.S., named after Section 510(k) of the Federal Food, Drug, and Cosmetic Act.
Where does this site get its data?
All data is sourced from official government APIs: FDA Open API, ClinicalTrials.gov, PubMed/NCBI, SEC EDGAR, and NMPA. We do not generate or modify the underlying data. Each page links back to its official source.
How often is the site updated?
The site is automatically rebuilt daily. New device approvals typically appear within 24 hours of publication by the FDA.
Does this site provide medical advice?
No. This site is for informational purposes only. It does NOT constitute medical advice, diagnosis, treatment, or investment recommendations. Always consult a qualified professional or the original regulatory source.
What is the difference between 510(k) and PMA?
510(k) clearance is for devices substantially equivalent to existing predicates. PMA (Premarket Approval) is required for high-risk Class III devices and requires clinical trial data demonstrating safety and effectiveness.