How can you all ignore what substantive review means? Do you...

How can you all ignore what substantive review means? Do you realize how early you are in the process? Directly from the FDA:

During Substantive Review, the Lead Reviewer conducts a comprehensive review of the 510(k) submission and communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the 510(k) submission.The Substantive Interaction communication is typically: an email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or an Additional Information (AI) request which places the submission on hold.

So, April 30 510k submission lodged. August 24 Substantive Review started. So what should have taken 15 up to 60 days took 116. Minimum is 2x to the schedule, but could be 7-8x. Also, in 2016, the AVERAGE 510k took 177 days. Why could we assume a new product from a new company is even going to get the average. Software products of this type can take far longer. DYOR.

MOST Substantive Reviews enter the Interactive Review or get an AI request, which adds more time, especially for new or non-incremental products. Why on earth do many of the posters here reasonably believe this is going to happen in mere days?

Pumpers has to be the only reason. Please do your research and become familiar with the 510k process. Most of what is posted to this board is pure bizzo.