Stelo Glucose Biosensor System— 510(k) K262472
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K262472 for Stelo Glucose Biosensor System, Substantially Equivalent on 2026-08-11. Applicant: Dexcom, Inc.. Device class: 2.
Summary
Dexcom's Stelo Glucose Biosensor System is filed under product code SBH, over-the-counter integrated continuous glucose monitors for non-intensive glucose management. The record gives no model numbers.
Class II, 21 CFR 862.1355. Clinical Chemistry is both the classification panel and the review panel, and the submission type is Special.
Dexcom filed from San Diego, California. The decision came 25 calendar days after receipt (July 17 to August 11, 2026), and it was substantially equivalent.
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
- Special
- 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
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