How long it takes the US FDA to approve 510(k) submissions

How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.Every year Emergo examines published data on medical devices cleared by the US Food and Drug Administration (FDA). The 15,000+ device clearances we analyzed in March 2017 went through the FDA’s Premarket Notification program, known as the 510(k) process. Technically, the FDA does not “approve” devices; they clear them for sale in the US. The 510(k) process applies to nearly all Class 2 devices, and less than 10% of Class 1 devices. We sorted all devices based on the date they were cleared by FDA, not the date they were submitted. Want to see average review time for YOUR specific device? Be sure to try our FDA 510(k) calculator (opens new window) which shows the historical average review times for specific devices cleared by FDA during the last five years.

Download our 2017 report:


Some highlights from the March 2017 analysis:

FDA 510(k) submissions cleared in 2016: 2,957

PDF also shows data from 2012, 2013, 2014 and 2015, plus data back to 1976!

Average time to get a 510(k) cleared in 2016: 177 days

PDF also shows five year trend plus timeframes for Special and Abbreviated 

510(k) applications cleared within 3 months: 19%

PDF also shows how many get cleared by FDA within 6, 9 and 12 months

Average time to get radiology products cleared: 112 days

PDF also shows how long it takes to get approval for 15 other device categories.

510(k) submissions by companies in US: 59.7%

PDF also shows many other countries and trend in their submissions over time.


Learn more about how Emergo can assist in preparing your 510(k) submission

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