SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET— 510(k) K962663

Substantially Equivalent

Solopak Medical Products, Inc.

FDA 510(k) clearance K962663 for SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET, Substantially Equivalent on 1996-10-04. Applicant: Solopak Medical Products, Inc..

Clearance details

Applicant: Solopak Medical Products, Inc.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 1996-07-08
Decision date: 1996-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.