Ezmanager Plus
FDA 510(k) K022394 · Animas Corp.
510(k) numberK022394
Submission
- Device name
- Ezmanager Plus
- Applicant
- Animas Corp.
Frazer, PA, US - Received
- July 23, 2002
- Decision date
- June 5, 2003
- 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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| K262153 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/02/2026SE |
| K253534 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical | 04/08/2026SE |
| 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 |
| 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 Ezmanager Plus cleared by the FDA?
Ezmanager Plus (K022394) received a 510(k) decision of Substantially Equivalent on June 5, 2003, 317 days after the submission was received.
What is the product code of K022394?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.