US manufacturers seeking clearance for a new device usually submit a Traditional 510(k) application, also known as a Premarket Notification (PMN) or Premarket Approval (PMA) application, to the Food and Drug Administration (FDA). The submission type depends on the device’s regulatory classification under 21 CFR 862–892. Most Class I devices are exempt from the 510(k) requirement; most Class II and a few Class III devices must have a cleared 510(k); and most Class II...