Cleared Traditional

Stelo Glucose Biosensor System

K234070 · Dexcom, Inc. · Chemistry

Mar 2024

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K234070 is an FDA 510(k) clearance for the Stelo Glucose Biosensor System, a Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter (Class II — Special Controls, product code SAF), submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on March 5, 2024, 74 days after receiving the submission on December 22, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K234070 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	SAF — Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter
Device Class	Class II — 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.