Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor Do
FDA 510(k) K021439 · Animas Corp.
510(k) numberK021439
Submission
- Device name
- Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor Do
- Applicant
- Animas Corp.
Frazer, PA, US - Received
- May 6, 2002
- Decision date
- May 29, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K240158 | Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/04/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | Medtronic Minimed | 07/02/2024SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | Insulet Corporation | 04/24/2023SE |
| K210714 | Extended ReservoirLZG · Traditional | Medtronic Minimed, Inc. | 04/06/2022SE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional | Insulet Corporation | 08/13/2021SE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 10/21/2019SE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 06/01/2018SE |
More from Insulet Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K080639 | Symphony Glucose Management SystemLZG · Traditional | 06/24/2008SE |
| K080587 | Ez Manager Max Diabetes Management SoftwareMRZ · Traditional | 05/15/2008SE |
| K063674 | Ezmanager Max Diabetes Management SoftwareLZG · Traditional | 03/30/2007SE |
| K042873 | Animas Model IR1250 Insulin Infusion PumpLZG · Traditional | 12/10/2004SE |
| 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 |
| K012754 | Ez Set Infusion SetFPA · Traditional | 08/27/2001SE |
| K993184 | R1000 Series Insulin PumpLZG · Traditional | 02/10/2000SE |
Questions and answers
When was Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor Do cleared by the FDA?
Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor Do (K021439) received a 510(k) decision of Substantially Equivalent on May 29, 2002, 23 days after the submission was received.
What is the product code of K021439?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.