Guides

Guides built on public data

Short answers to the questions device teams look up most, each with the numbers behind it and a free tool to go further.

How long does a 510(k) take?Review times by 510(k) type and year, from the public record, with n.
How to find a predicate deviceProduct code, cleared devices, 510(k) summaries and the candidate's safety record.
How to search MAUDESearch adverse event reports by product code and read them without the usual traps.
UDI barcode format, explainedThe device identifier, lot, serial and dates, decoded on a worked example.
Accelerated aging time tableASTM F1980 chamber days for 6 months to 5 years at 50 to 60 °C.
FDA product codesEvery code with enough 510(k) history: class, regulation, review times and standards.
FDA-recognized standardsRecognition numbers, extent, excluded clauses and transition dates.