FDA Product Code MEB: Pump, Infusion, Elastomeric
Leading manufacturers include Epic Medical Pte. , Ltd. and First Medical Source, LLC.
FDA 510(k) Cleared Pump, Infusion, Elastomeric Devices (Product Code MEB)
About Product Code MEB - Regulatory Context
510(k) Submission Activity
88 total 510(k) submissions under product code MEB since 1992, with 88 receiving FDA clearance (average review time: 118 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MEB have taken an average of 258 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
MEB devices are reviewed by the General Hospital panel. Browse all General Hospital devices →