SOLUTION ADMINISTRATION SET (W/O NEEDLE)— 510(k) K821995

Substantially Equivalent

Bertex Laboratories, Inc.

FDA 510(k) clearance K821995 for SOLUTION ADMINISTRATION SET (W/O NEEDLE), Substantially Equivalent on 1982-08-05. Applicant: Bertex Laboratories, Inc..

Clearance details

Applicant: Bertex Laboratories, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1982-07-07
Decision date: 1982-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.