Cleared Traditional

K234070 - Stelo Glucose Biosensor System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence.

K234070 · Dexcom, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
74d
Days
Class 2
Risk

K234070 is an FDA 510(k) clearance for the Stelo Glucose Biosensor System. Classified as Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter (product code SAF), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on March 5, 2024 after a review of 74 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

Submission Details

510(k) Number K234070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date March 05, 2024
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SAF Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, 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 Monitoring 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 In Persons Who Are Not On Insulin And Do Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Monitoring 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. Device Output Should Not Be Used To Make Treatment Decisions Without Consulting With A Qualified Healthcare Professional.
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.