510(k) K262472

Device: Stelo Glucose Biosensor System
Applicant: Dexcom, Inc.
510(k) number: K262472
Product code: SBH
Decision: Substantially Equivalent (SESE)
Decision date: 2026-08-11
Date received: 2026-07-17
Regulation: 862.1355
Classification name: Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K260935	Stelo Glucose Biosensor System	Dexcom, Inc.	2026-06-12
K233861	Libre Rio Continuous Glucose Monitoring System	Abbott Diabetes Care	2024-06-07