AUTOFUSER AMBULATORY INFUSION PUMP— 510(k) K041585

Name: FDA 510(k) clearance K041585
Creator: U.S. Food and Drug Administration
Published: 2004-08-26

Substantially Equivalent

Algos, LC

FDA 510(k) clearance K041585 for AUTOFUSER AMBULATORY INFUSION PUMP, Substantially Equivalent on 2004-08-26. Applicant: Algos, LC. Device class: 2.

Clearance details

Applicant: Algos, LC
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2004-06-14
Decision date: 2004-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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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.