How long will FDA take? Ask the record.
Enter an FDA product code and get the real distribution of 510(k) decision times - median, typical range, and the slow tail - computed from every decision since 1976 and refreshed weekly.
Try a code
Blood glucose monitors, pulse oximeters, surgical staplers - every device family has its own clock.
Where the numbers come from
Every 510(k) record since 1976 carries a received date and a decision date. We compute the spread per product code - no models, no guessing, just the record.
Why it matters
"How long will FDA take?" decides launch plans, funding runways and client expectations. Answer it with the actual distribution, not folklore.