Stelo Glucose Biosensor System

FDA 510(k) K260935 · Dexcom, Inc.

Substantially Equivalent

510(k) numberK260935

Submission

Device name
Stelo Glucose Biosensor System
Applicant
Dexcom, Inc.
San Diego, CA, US
Received
March 20, 2026
Decision date
June 12, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SBH – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1355
Specialty
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…

Other 510(k)s with product code SBH

510(k)DeviceApplicantDecision
K262472Stelo Glucose Biosensor SystemSBH · Special Dexcom, Inc.08/11/2026SE
K233861Libre Rio Continuous Glucose Monitoring SystemSBH · Traditional Abbott Diabetes Care06/07/2024SE

More from Abbott Diabetes Care

510(k)DeviceDecision
K262472Stelo Glucose Biosensor SystemSBH · Special 08/11/2026SE
K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…QBJ · Traditional 06/08/2026SE
K261359Stelo Glucose Biosensor SystemSAF · Special 05/21/2026SE
K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…QBJ · Traditional 02/03/2026SE
K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…QBJ · Special 12/17/2025SE
K252818Dexcom Smart BasalQRX · Traditional 11/18/2025SE
K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ · Traditional 04/09/2025SE
K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Special 04/23/2024SE
K234070Stelo Glucose Biosensor SystemSAF · Traditional 03/05/2024SE
K234133Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Traditional 02/26/2024SE

Questions and answers

When was Stelo Glucose Biosensor System cleared by the FDA?

Stelo Glucose Biosensor System (K260935) received a 510(k) decision of Substantially Equivalent on June 12, 2026, 84 days after the submission was received.

What is the product code of K260935?

The FDA product code is SBH – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1355.