510k.txt Apr 2026

See how many AI-powered diagnostic tools were cleared last year versus five years ago.

While most people search the FDA website one device at a time, power users download the raw files to perform mass analysis. With 510K.txt , you can: 510K.txt

Instead of starting from scratch with massive clinical trials (like a drug would), a manufacturer uses the 510(k) process to prove their device is "substantially equivalent" to one already on the market—known as a . Why you should care about the raw data See how many AI-powered diagnostic tools were cleared

The file is typically a tab-delimited text document containing fields like: Device 510(k) Overview - openFDA Why you should care about the raw data

Analyze "cleared" dates to estimate how long the FDA currently takes to review specific types of technology. What's inside the file?