I would highly suggest using the 3rd party review process if possible. We just put through a Class II device that was cleared in 17 days. Great process if your device is eligible.
KVRAD - would like more details as to how you accomplished this for a Class II device. Our device that is going to be filed is a new version of an already approved device and we are a small business. Thanks for your reply, we would love to achieve anywhere near this time, customers are hungry for the revised version.
ps.: Special 510k is a good idea in case your company QMS readiness allows the issuance of the related conformance statements.