510(k) K262472
K262472 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "Stelo Glucose Biosensor System". The FDA issued a decision of Substantially Equivalent on August 11, 2026. The device falls under product code SBH (Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter), a Class II device regulated under 21 CFR 862.1355. Dexcom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2026
- Date Received
- July 17, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 862.1355
- Review Panel
- CH
- Submission Type
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.