Product code SBH— Clinical Chemistry

“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.”

FDA has cleared 3 devices under product code SBH between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20262 clearances
• 20241 clearance

• Dexcom, Inc.2 clearances
• Abbott Diabetes Care1 clearance

• K262472 — Stelo Glucose Biosensor SystemDexcom, Inc.·2026-08-11
• K260935 — Stelo Glucose Biosensor SystemDexcom, Inc.·2026-06-12
• K233861 — Libre Rio Continuous Glucose Monitoring SystemAbbott Diabetes Care·2024-06-07