FDA 510(k) clearance · back to tracker

Stelo Glucose Biosensor System

Dexcom, Inc. cleared K261359 on 2026-05-21, decision: substantially equivalent

K-number

K261359

Sponsor

Dexcom, Inc.

Device

Stelo Glucose Biosensor System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-21

Product code

SAF

Advisory committee

Clinical Chemistry

Medical specialty

Clinical Chemistry

Regulation number

862.1355

Official FDA record

Open K261359on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.