This is a tool for searching and analyzing data about medical devices cleared by the FDA's 510(k) program. It allows you to search for devices, find detailed information, and understand device predicate ancestry. The data is sourced from the official FDA 510(k) database and is available for free.
Features
Search for devices
Allows users to search a wide array of medical devices approved by the FDA using the 510(k) process. It provides detailed device information from the official FDA database.
Find device predicate ancestry
This feature lets users explore the predicate ancestry of a device, showing the relationships between current and past products based on FDA approvals, which can help understand the innovation and changes in medical devices.
Device Search
Allows users to search for medical devices by name or keyword to find detailed information about FDA 510(k) clearances.
Predicate Device Ancestry Understanding
Helps consumers, device manufacturers, and the FDA understand the predicate device ancestry of devices cleared through the 510k process.
Manual PDF Summary Examination
Collects all available 510k PDF summaries and uses OCR to find predicates, simplifying the data and showing relationships between recalled and currently marketed devices.
Feedback Form
Allows users to submit comments, suggestions, or criticisms. Users can enter their name, email, and a message in the provided fields and submit the form.