Cleared Traditional

Signos Glucose Monitoring System

K250106 · Signos, Inc. · Chemistry
Mar 2025
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K250106 is an FDA 510(k) clearance for the Signos Glucose Monitoring System, a Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter (Class II — Special Controls, product code SAF), submitted by Signos, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on March 21, 2025, 65 days after receiving the submission on January 15, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number K250106 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2025
Decision Date March 21, 2025
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code SAF — Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1355
Definition 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 Glucose Monitoring Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Excluding Devices Intended To Control The Delivery Of Insulin, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices. Device Output Should Not Be Used To Make Treatment Decisions Without Consulting With A Qualified Healthcare Professional.