Great Basin Scientific Inc. (fka GBSNQ)

[copperking]

How long it takes the FDA to "approve" a 510(k) submission

Key takeaways from this year’s analysis:(2014)
A company submitting a 510(k) today has a 22% chance of getting it cleared within 3 months, and a 61% chance of getting it cleared within 6 months.
There were 3,173 devices cleared through the 510(k) program in 2014, a 4.5% increase over 2013 but similar to numbers seen in 2011 and 2012.
Radiological and Orthopedic devices tend to take the least amount of time to clear, averaging 135 and 140 days respectively in 2014.
Third Party Reviewers clear devices in 68 days on average, more than 110 days faster than internal FDA reviewers. Caveat: Complex devices do not qualify for this program.
Over the last 15 years, the FDA has been taking progressively longer to clear 510(k) submissions, which now averages about 6 months.

http://www.emergogroup.com/resources/research/fda-510k-review-times-research