FDA Product Code SAF: Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter
An Integrated Continuous Glucose Monitoring System (icgm) For Non-intensive Glucose Monitoring 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 In Persons Who Are Not On Insulin And Do Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Monitoring 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. Device Output Should Not Be Used To Make Treatment Decisions Without Consulting With A Qualified Healthcare Professional.
Leading manufacturers include Abbott, Dexcom, Inc. and Signos, Inc..
FDA 510(k) Cleared Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter Devices (Product Code SAF)
About Product Code SAF - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code SAF since 2024, with 3 receiving FDA clearance (average review time: 112 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 SAF have taken an average of 131 days to reach a decision - up from 74 days historically. Manufacturers should account for longer review timelines in current project planning.
SAF devices are reviewed by the Chemistry panel. Browse all Chemistry devices →