T1D1— 510(k) K252104

Substantially Equivalent

Comerge AG

FDA 510(k) clearance K252104 for T1D1, Substantially Equivalent on 2025-08-20. Applicant: Comerge AG.

Clearance details

Applicant: Comerge AG
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 2025-07-03
Decision date: 2025-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

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.