# K250106: Signos Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Signos, Inc.
- Decided: Mar 21, 2025 after 65 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 5.

## Indications for use
The Signos Glucose Monitoring System is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Signos Glucose Monitoring System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Signos Glucose Monitoring System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users to maintain a healthy weight. 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/K250106
Methodology: https://510kreport.com/methodology