FDA Product Code JOJ: Indicator, Physical/chemical Sterilization Process
FDA product code JOJ covers physical and chemical sterilization process indicators.
These indicators use temperature-sensitive inks, chemical reactions, or physical changes to confirm that instruments have been exposed to sterilization conditions. They provide a visual, immediate confirmation that packages have passed through the sterilization cycle, distinguishing processed from unprocessed items.
JOJ devices are Class II medical devices, regulated under 21 CFR 880.2800 and reviewed by the FDA General Hospital panel.
Leading manufacturers include 3M Company, Steris and STERIS Corporation.
FDA 510(k) Cleared Indicator, Physical/chemical Sterilization Process Devices (Product Code JOJ)
About Product Code JOJ - Regulatory Context
510(k) Submission Activity
265 total 510(k) submissions under product code JOJ since 1976, with 264 receiving FDA clearance (average review time: 152 days).
Submission volume has increased in recent years - 17 submissions in the last 24 months compared to 12 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JOJ have taken an average of 106 days to reach a decision - down from 155 days historically, suggesting improved FDA processing for this classification.
JOJ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →