MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS— 510(k) K033039

Name: FDA 510(k) clearance K033039
Creator: U.S. Food and Drug Administration
Published: 2003-10-07

Substantially Equivalent

Mckinley, Inc.

FDA 510(k) clearance K033039 for MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS, Substantially Equivalent on 2003-10-07. Applicant: Mckinley, Inc.. Device class: 2.

Clearance details

Applicant: Mckinley, Inc.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2003-09-29
Decision date: 2003-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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K990461 — MCKINLEY SP DISPOSABLE INFUSION PUMP1999-06-30
K982256 — OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP1998-09-30

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.