SAF · Class II · 21 CFR 862.1355

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 Dexcom, Inc., Abbott and Signos, Inc..

4
Total
4
Cleared
91d
Avg days
2024
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 46d recently vs 136d historically

FDA 510(k) Cleared Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter Devices (Product Code SAF)

4 devices
1–4 of 4
Cleared May 21, 2026
Stelo Glucose Biosensor System
K261359
Dexcom, Inc.
Chemistry · 27d
Cleared Mar 21, 2025
Signos Glucose Monitoring System
K250106
Signos, Inc.
Chemistry · 65d
Cleared May 29, 2024
Lingo Glucose System
K233655
Abbott
Chemistry · 197d
Cleared Mar 05, 2024
Stelo Glucose Biosensor System
K234070
Dexcom, Inc.
Chemistry · 74d

About Product Code SAF - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code SAF since 2024, with 4 receiving FDA clearance (average review time: 91 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - SAF Product Code

Recent submissions under SAF have taken an average of 46 days to reach a decision - down from 136 days historically, suggesting improved FDA processing for this classification.

SAF devices are reviewed by the Chemistry panel. Browse all Chemistry devices →