RAP charting, page-84

Resapp has very clearly stated (IMO very realistic) in their Investor Presentation, under clinical and regulatory plan, the time frame for clinical trials and the path/category for FDA application i.e either 501K or de novo submission.

This may be fast tracked if they take Expedited Access Pathway Program ( EAP). This probably will be known during pre-submission meeting with FDA.  

Attached link below may give you an insight for those who want to know about regulatory pathway.

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm441467.htm

IMO DYOR