Stelo Glucose Biosensor System— 510(k) K260935
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K260935 for Stelo Glucose Biosensor System, Substantially Equivalent on 2026-06-12. Applicant: Dexcom, Inc.. Device class: 2.
Summary
Dexcom's Stelo Glucose Biosensor System is filed under SBH, over-the-counter integrated continuous glucose monitors for non-intensive glucose management. The record doesn't list the system's components.
Class II, 21 CFR 862.1355. Clinical Chemistry is both the classification panel and the review panel. It was a Traditional 510(k).
Dexcom filed from San Diego, California. The decision came 84 calendar days after receipt (March 20 to June 12, 2026).
Clearance details
- Applicant
- Dexcom, Inc.
- Product code
- Product code SBH
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code SBH
view allMore clearances from Dexcom, Inc.
view all- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K261359 — Stelo Glucose Biosensor System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K252818 — Dexcom Smart Basal
Data sourced from openFDA. This site is unofficial and independent of the FDA.