Cleared Traditional

K260935 - Stelo Glucose Biosensor System

K260935 is an FDA 510(k) clearance for Stelo Glucose Biosensor System, manufactured by Dexcom, Inc.. The device is a Class 2 Chemistry device with product code SBH cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K260935 · Dexcom, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
84d
Days
Class 2
Risk

K260935 is an FDA 510(k) clearance for the Stelo Glucose Biosensor System. Classified as Integrated Continuous Glucose Monitor For Non-intensive Glucose Management, Over-the-counter (product code SBH), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on June 12, 2026 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1355 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dexcom, Inc. devices

FDA 510(k) Submission Details - K260935

510(k) Number K260935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2026
Decision Date June 12, 2026
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

SBH Device Classification - Class 2, Special Controls

Product Code SBH Integrated Continuous Glucose Monitor For Non-intensive Glucose Management, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1355
Definition 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 Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Management Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Excluding Devices Intended To Control The Delivery Of Insulin, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04794478 Completed Interventional Industry-sponsored

Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System

482
Patients (actual)
12
Sites
Other
Purpose
Open label
Masking
Condition studied Diabetes Mellitus
Study design Single group
Eligibility All sexes · 2 Years+
Sponsor DexCom, Inc. (industry)
Started 2021-02-19 → Primary completion 2021-08-09 → Completed 2021-10-31
Primary outcome
Dexcom Continuous Glucose Monitoring System Performance
Secondary outcome
System Related Adverse Device Effects
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov