Animas Model IR1250 Insulin Infusion Pump
FDA 510(k) K042873 · Animas Corp.
510(k) numberK042873
Submission
- Device name
- Animas Model IR1250 Insulin Infusion Pump
- Applicant
- Animas Corp.
West Chester, PA, US - Received
- October 18, 2004
- Decision date
- December 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K032257 | Model Ir 1200 Insulin PumpLZG · Traditional | 10/16/2003SE |
| K022394 | Ezmanager PlusLZG · Traditional | 06/05/2003SE |
| K021700 | Animus Ezserter Infusion Set InserterKZH · Traditional | 06/04/2002SE |
| K021439 | Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle…LZG · Special | 05/29/2002SE |
| K012754 | Ez Set Infusion SetFPA · Traditional | 08/27/2001SE |
| K993184 | R1000 Series Insulin PumpLZG · Traditional | 02/10/2000SE |
Questions and answers
When was Animas Model IR1250 Insulin Infusion Pump cleared by the FDA?
Animas Model IR1250 Insulin Infusion Pump (K042873) received a 510(k) decision of Substantially Equivalent on December 10, 2004, 53 days after the submission was received.
What is the product code of K042873?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.