FDA Product Code KXK: Source, Brachytherapy, Radionuclide
Leading manufacturers include Isoaid, LLC and Oncopatch, Inc..
FDA 510(k) Cleared Source, Brachytherapy, Radionuclide Devices (Product Code KXK)
About Product Code KXK - Regulatory Context
510(k) Submission Activity
151 total 510(k) submissions under product code KXK since 1980, with 151 receiving FDA clearance (average review time: 131 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under KXK have taken an average of 218 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
KXK devices are reviewed by the Radiology panel. Browse all Radiology devices →