ACCU-CHEK ULTRFLEX INFUSION SET— 510(k) K101196

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K101196 for ACCU-CHEK ULTRFLEX INFUSION SET, Substantially Equivalent on 2010-08-27. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2010-04-29
Decision date: 2010-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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.