Every 510(k) makes the same argument, substantial equivalence to a predicate, and pays the same user fee ($28,653 in FY2027, $7,163 with small-business status). What differs is how much FDA has to read, and how fast it aims to answer.
The default: full test reports and a complete comparison with the predicate. Any device can use it. FDA's review goal is 90 FDA days.
For a change to your own legally marketed device. FDA's 2019 guidance makes it fit when the change can be evaluated with well-established methods and the results can be reviewed in a summary or risk-analysis format. Design controls do much of the work: you show the change went through them. The review goal is 30 days. Changes that need clinical data or new test methods generally go Traditional. Try the Special 510(k) check.
Before either, ask whether the change needs a new 510(k) at all. FDA's change guidance walks through that decision, and many changes end in a documented rationale (a letter to file) rather than a submission.
For a device that leans on FDA guidance, special controls or recognized consensus standards. You can declare conformity and summarise rather than submit every report. It suits devices whose testing is well covered by recognized standards. The review goal is the Traditional one.
General information, not regulatory advice. FDA decides every classification and submission; confirm your route with FDA (a Pre-Sub or a 513(g)) or a qualified regulatory professional. Fees and review goals are planning figures; check FDA's current schedule.
More: Choosing an FDA pathway · De Novo in plain terms · 513(g) requests in plain terms · Pre-Subs (Q-Submissions) in plain terms · The Breakthrough Devices Program