"Cleared" means a 510(k) showed substantial equivalence; "approved" means a PMA showed independent safety and effectiveness. They are not interchangeable.
FD&C Act §510(k) vs. §515
What people get wrong
Calling a cleared device "FDA approved" is a labeling violation, not a technicality — it overstates the evidentiary bar the device actually met. Marketing, investor decks, and packaging all get flagged for this, and it's one of the most common device-labeling mistakes FDA cites. The fix is simple: say "FDA cleared" for a 510(k), and reserve "FDA approved" for a real PMA or NDA.
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