Dear oh dear oh dear,
Have no idea where you got the pretty template from but this is reality.Typical FDA 510(k) Review Cycle (Calendar Days)
Despite what you may have read, it is unusual to get a 510(k) cleared in less than three months. Plan on six months from the hopeful day you submit until the joyous occasion when you pop the champagne cork and are holding the substantial equivalence letter in your hand. In all fairness, because such a high percentage of companies receive AI requests from FDA, the amount of total time that FDA spends reviewing your submission is only slightly longer than the amount of time companies spend replying to FDA AI requests. The average time to clearance is around five or six months but that also varies by medical specialty.
Why 510(k) Submissions Get Rejected as NSE
