MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO— 510(k) K021439

Name: FDA 510(k) clearance K021439
Creator: U.S. Food and Drug Administration
Published: 2002-05-29

Substantially Equivalent

Animas Corp.

FDA 510(k) clearance K021439 for MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO, Substantially Equivalent on 2002-05-29. Applicant: Animas Corp.. Device class: 2.

Clearance details

Applicant: Animas Corp.
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2002-05-06
Decision date: 2002-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Frazer, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.