Signos Glucose Monitoring System— 510(k) K250106

Substantially Equivalent

Signos, Inc.

FDA 510(k) clearance K250106 for Signos Glucose Monitoring System, Substantially Equivalent on 2025-03-21. Applicant: Signos, Inc..

Clearance details

Applicant: Signos, Inc.
Product code: Code SAF
Advisory panel: Clinical Chemistry
Date received: 2025-01-15
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code SAF

product code SAF

Injury: 164
Malfunction: 1,935
Total: 2,099

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.