DBLG2— 510(k) K251152

Substantially Equivalent

Diabeloop

FDA 510(k) clearance K251152 for DBLG2, Substantially Equivalent on 2025-12-19. Applicant: Diabeloop.

Clearance details

Applicant: Diabeloop
Product code: Code QJI
Advisory panel: Clinical Chemistry
Date received: 2025-04-14
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grenoble, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

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.