Stelo Glucose Biosensor System

FDA 510(k) K234070 · Dexcom, Inc.

Substantially Equivalent

510(k) numberK234070

Submission

Device name
Stelo Glucose Biosensor System
Applicant
Dexcom, Inc.
San Diego, CA, US
Received
December 22, 2023
Decision date
March 5, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SAF – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1355
Specialty
Clinical Chemistry

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…

Other 510(k)s with product code SAF

510(k)DeviceApplicantDecision
K261359Stelo Glucose Biosensor SystemSAF · Special Dexcom, Inc.05/21/2026SE
K250106Signos Glucose Monitoring SystemSAF · Traditional Signos, Inc.03/21/2025SE
K233655Lingo Glucose SystemSAF · Traditional Abbott05/29/2024SE

More from Abbott

510(k)DeviceDecision
K262472Stelo Glucose Biosensor SystemSBH · Special 08/11/2026SE
K260935Stelo Glucose Biosensor SystemSBH · Traditional 06/12/2026SE
K261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose…QBJ · Traditional 06/08/2026SE
K261359Stelo Glucose Biosensor SystemSAF · Special 05/21/2026SE
K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous…QBJ · Traditional 02/03/2026SE
K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous…QBJ · Special 12/17/2025SE
K252818Dexcom Smart BasalQRX · Traditional 11/18/2025SE
K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ · Traditional 04/09/2025SE
K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Special 04/23/2024SE
K234133Dexcom G7 Continuous Glucose Monitoring SystemQBJ · Traditional 02/26/2024SE

Questions and answers

When was Stelo Glucose Biosensor System cleared by the FDA?

Stelo Glucose Biosensor System (K234070) received a 510(k) decision of Substantially Equivalent on March 5, 2024, 74 days after the submission was received.

What is the product code of K234070?

The FDA product code is SAF – Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1355.