# K261359: Stelo Glucose Biosensor System

- Pathway: 510(k) (Special)
- Applicant: Dexcom, Inc.
- Decided: May 21, 2026 after 27 days
- Product code: SAF (Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to DEN170088 (2018). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234070: Stelo Glucose Biosensor System, Dexcom, Inc. (2024) Summary page 6.

## Indications for use
The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

Source page: https://510kreport.com/device/K261359
Methodology: https://510kreport.com/methodology