SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET— 510(k) K963355

Name: FDA 510(k) clearance K963355
Creator: U.S. Food and Drug Administration
Published: 1996-10-04

Substantially Equivalent

Solopak Medical Products, Inc.

FDA 510(k) clearance K963355 for SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET, Substantially Equivalent on 1996-10-04. Applicant: Solopak Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Solopak Medical Products, Inc.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1996-08-26
Decision date: 1996-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Solopak Medical Products, Inc.

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K970800 — MAXCESS NEEDLEFREE - Y- SITE (100713)1997-04-02
K962663 — SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET1996-10-04
K960661 — MAXCESS NEEDLE FREE CONNECTOR (8200)1996-03-21

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.