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.
DQA - what the record says
726 measurable FDA decisions under this product code.
125 daysmedian decision time
80-217middle 50% of submissions
326 days90% decided within
262 daysmedian since 2023
Plain English: half of DQA submissions received a decision within 125 days; the typical range is 80-217 days, and 9 in 10 were decided within 326 days. Plan the slow case, hope for the fast one.
Distribution of decision times
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Days to decision, 30-day buckets. Highlighted bars = the middle 50%.
By submission pathway
| Pathway | Median | Decisions |
|---|---|---|
| Special | 60 days | 140 |
| Abbreviated | 100 days | 12 |
| Traditional | 153 days | 574 |
Special 510(k)s (modifications to your own cleared device) typically run far faster than Traditional - pathway choice matters as much as the code.