De Novo
A route for low- to moderate-risk devices with no existing product to compare against.
A new device may have nothing to point at as a predicate, which rules out a 510(k), while its risk profile does not justify a PMA. De Novo closes that gap: the FDA classifies the device as Class I or Class II and authorises it in one step. A granted De Novo can then act as a predicate itself, so it opens a category for the devices that follow.