FDA.reportPublic FDA data

510(k) K261359

Device
Stelo Glucose Biosensor System
Applicant
Dexcom, Inc.
510(k) number
K261359
Product code
SAF
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-21
Date received
2026-04-24
Regulation
862.1355
Classification name
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, 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#

Contact
Ginny Hu
Address
6340 Sequence Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SAF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250106Signos Glucose Monitoring SystemSignos, Inc.2025-03-21
K233655Lingo Glucose SystemAbbott2024-05-29
K234070Stelo Glucose Biosensor SystemDexcom, Inc.2024-03-05