FDA 510(k) Medical Device Clearance Dataset (1980-2025)

Structured dataset of 166,200 FDA 510(k) medical device clearance records spanning 1980-2025.The dataset is derived from publicly available FDA CDRH flat files and normalized for regulatory research, machine learning, and medical device analytics. It includes device metadata, manufacturer information, classification codes, review panels, and clearance outcomes. This dataset is maintained as part of 510kDatabase.net and is continuously updated following FDA monthly releases. The dataset is derived from U.S. FDA public 510(k) records:https://www.fda.gov/medical-devices/510k-clearances/downloadable-510k-files Project website:https://www.510kdatabase.net