FDA Product Code SBA: Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
An Integrated Continuous Glucose Monitoring System (icgm) With Sensor Containing Dexamethasone Acetate Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control. The Dexamethasone Acetate Coating Is Intended To Reduce Inflammation At The Sensor Insertion Site.
Leading manufacturers include Senseonics, Incorporated.
FDA 510(k) Cleared Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate Devices (Product Code SBA)
About Product Code SBA - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SBA since 2024, with 1 receiving FDA clearance (average review time: 195 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under SBA have taken an average of 126 days to reach a decision - down from 264 days historically, suggesting improved FDA processing for this classification.
SBA devices are reviewed by the Chemistry panel. Browse all Chemistry devices →