FDA Product Code SFU: Glucose Range Monitoring System
A Glucose Range Monitoring System (grm) Is Intended To Automatically Measure Glucose In The Body And Provide Qualitative Or Semi-quantitative Information About Glucose Levels Or Trends Continuously Or Frequently. Grm Systems Are Intended To Support General User Awareness Of Glucose Ranges Related To Glycemic Control. Outputs From Grm Systems Do Not Represent Quantitative Glucose Concentration Values And Grm Systems Are Not Intended To Be Used For Acute Medical Decision-making, Such As Insulin Dosing Or Medication Adjustment.
Leading manufacturers include Biolinq Incorporated.
FDA 510(k) Cleared Glucose Range Monitoring System Devices (Product Code SFU)
About Product Code SFU - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFU since 2025, with 0 receiving FDA clearance (average review time: 270 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SFU devices are reviewed by the Chemistry panel. Browse all Chemistry devices →