MODEL IR 1200 INSULIN PUMP— 510(k) K032257

Substantially Equivalent

Animas Corp.

FDA 510(k) clearance K032257 for MODEL IR 1200 INSULIN PUMP, Substantially Equivalent on 2003-10-16. Applicant: Animas Corp..

Clearance details

Applicant: Animas Corp.
Product code: Code LZG
Advisory panel: General Hospital
Date received: 2003-07-22
Decision date: 2003-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frazer, PA, US

Download summary PDF View on FDA.gov ↗

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.