ACCU-CHEK ULTRAFLEX INFUSION SET— 510(k) K122686

Substantially Equivalent

Roche Diabetes Care AG

FDA 510(k) clearance K122686 for ACCU-CHEK ULTRAFLEX INFUSION SET, Substantially Equivalent on 2012-11-16. Applicant: Roche Diabetes Care AG.

Clearance details

Applicant: Roche Diabetes Care AG
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2012-09-04
Decision date: 2012-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Burgdorf, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.