SIMPLICITY INFUSION PUMP MODEL 2100A— 510(k) K803078

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K803078 for SIMPLICITY INFUSION PUMP MODEL 2100A, Substantially Equivalent on 1981-01-28. Applicant: Critikon Company, LLC.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1980-12-05
Decision date: 1981-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.