FDA Product Code SBH: Integrated Continuous Glucose Monitor For Non-intensive Glucose Management, Over-the-counter
An Integrated Continuous Glucose Monitoring System (icgm) For Non-intensive Glucose Management Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time To Detect Euglycemic And Dysglycemic Glucose Levels Across The Range Spanning Clinically Significant Hypoglycemia And Hyperglycemia Levels In Persons Who Are Not On Insulin And Who Do Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Management Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Excluding Devices Intended To Control The Delivery Of Insulin, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices.
Leading manufacturers include Abbott Diabetes Care.
2
Total
2
Cleared
134d
Avg days
2024
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
84d
recently vs 184d historically
FDA 510(k) Cleared Integrated Continuous Glucose Monitor For Non-intensive Glucose Management, Over-the-counter Devices (Product Code SBH)
2 devices
About Product Code SBH - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SBH since 2024, with 2 receiving FDA clearance (average review time: 134 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - SBH Product Code
Recent submissions under SBH have taken an average of 84 days to reach a decision - down from 184 days historically, suggesting improved FDA processing for this classification.
SBH devices are reviewed by the Chemistry panel. Browse all Chemistry devices →