The four words
Approved means premarket approval (PMA), the pathway for Class III devices. Cleared means a 510(k): FDA found the device substantially equivalent to one already on the market. Granted means a De Novo request for a new, lower-risk device type. Listed means the establishment is registered and the device is listed. For most Class I devices, that is the whole premarket requirement.FDA: classify a deviceFDA: 510(k)
Why "listed" is not a badge
Registration and listing do not denote FDA approval, and representing them as if they did is itself misbranding.21 CFR 807.39 A Class I, 510(k)-exempt device is a legitimate, low-risk category; it just has not had its safety or effectiveness reviewed by FDA, and nobody should imply that it has.
What to check on any device
Ask for the product code and the regulation number, then look them up in FDA’s own database. The product code tells you the device type; the regulation tells you its class and whether it is exempt. A Class I exemption covers the device type’s established use only. A new intended use is outside it.21 CFR 878.9
Every device on this site shows those facts in its regulatory panel, with a link to the FDA record.
General information for licensed practices, not legal or medical advice. Sources are linked in the text.