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 and continuously or frequently measure glucose in bodily fluids, detecting euglycemic and dysglycemic levels in persons not on insulin who do not have significant risk of problematic hypoglycemia. The system reliably transmits glucose data to digitally connected devices (excluding insulin delivery controllers) and is an over-the-counter device not intended to independently direct treatment decisions. It is classified as FDA Class II (510(k) required) under regulation 862.1355 in the Clinical Chemistry specialty, with product code SAF. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SAF
- Device Class
- FDA class 2
- Regulation Number
- 862.1355
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261359 | Stelo Glucose Biosensor System | May 21, 2026 | Substantially Equivalent | Dexcom, Inc. |
| K250106 | Signos Glucose Monitoring System | Mar 21, 2025 | Substantially Equivalent | Signos, Inc. |
| K233655 | Lingo Glucose System | May 29, 2024 | Substantially Equivalent | Abbott |
| K234070 | Stelo Glucose Biosensor System | Mar 05, 2024 | Substantially Equivalent | Dexcom, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.