FDA Product Code OPP: Pump, Infusion, Insulin Bolus
The Device Is Adhered To The Body For Several Days For The Purpose Of Periodically Infusing An Insulin Bolus.
Leading manufacturers include Cequr SA.
FDA 510(k) Cleared Pump, Infusion, Insulin Bolus Devices (Product Code OPP)
About Product Code OPP - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code OPP since 2010, with 7 receiving FDA clearance (average review time: 144 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OPP have taken an average of 126 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.
OPP devices are reviewed by the Chemistry panel. Browse all Chemistry devices →