Traditional510k: Most companies introducing a new Class II device must submit aTraditional 510k Premarket Notification. This is a full submission with21 sections. FDA’s clearance of a Traditional 510k is 90 days
Special510k: This clearance is used when there is a design change or amodification to a device you have previously cleared that does not affect theintended use. FDA’s clearance of a Special 510k is 30 days.
Abbreviated510k: There are specific guidelines for this 510k clearance. There has to be guidance documents from FDA for the specific medical devicethat is to be cleared. A special control has been established by FDA forthis device and consensus standards. FDA’s clearance of an Abbreviated510k is 90 days
FDA 510k SubmissionReqiurement