MODEL IR 1200 INSULIN PUMP— 510(k) K032257
Substantially EquivalentAnimas Corp.
FDA 510(k) clearance K032257 for MODEL IR 1200 INSULIN PUMP, Substantially Equivalent on 2003-10-16. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Frazer, PA, US
Recent devices under product code LZG
view allMore clearances from Animas Corp.
view allAdverse 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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K032257
K-number listed on FDA's recall record- Z-0836-2013 — Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
- Z-0005-2013 — IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032257.
Data sourced from openFDA. This site is unofficial and independent of the FDA.