ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT— 510(k) K023098

Name: FDA 510(k) clearance K023098
Creator: U.S. Food and Drug Administration
Published: 2002-12-09

Substantially Equivalent

Mckinley Infuser

FDA 510(k) clearance K023098 for ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT, Substantially Equivalent on 2002-12-09. Applicant: Mckinley Infuser. Device class: 2.

Clearance details

Applicant: Mckinley Infuser
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2002-09-18
Decision date: 2002-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEB

view all

K250234 — SMARTeZ Elastomeric Infusion Pump (RS series)2026-04-24
K240624 — InfuLife2024-11-05
K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)2024-10-07
K181360 — ON-Q* Pump with Bolus2019-03-22
K151650 — SMARTez elastomeric infusion pump2016-04-04

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.