# K234070: Stelo Glucose Biosensor System

- Pathway: 510(k) (Traditional)
- Applicant: Dexcom, Inc.
- Decided: Mar 5, 2024 after 74 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: 7 generations back to DEN170088 (2018). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231081: Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom, Inc. (2023) Summary page 5.

## Most influential descendants
- K260935: Stelo Glucose Biosensor System (2026), 1 descendant of its own
- K262472: Stelo Glucose Biosensor System (2026), 0 descendants of its own
- K261359: Stelo Glucose Biosensor System (2026), 0 descendants of its own
- K250106: Signos Glucose Monitoring System (2025), 0 descendants of its own

## 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/K234070
Methodology: https://510kreport.com/methodology