Most Class I recalls include devices cleared through the 510(k) pathway
Number of Class I recalls by device authorization type, January 2018 to June 2022.
A pie chart with 510(k) clearance taking up more than three-quarters of the total.
510(k) clearance
Premarket approval
Other / Multiple
Unknown
510(k) clearance
146
Premarket approval
33
Other / Multiple
8
Unknown
2
