Amigo Insulin Pump
FDA 510(k) K071613 · Nipro Diabetes Systems, Inc.
510(k) numberK071613
Submission
- Device name
- Amigo Insulin Pump
- Applicant
- Nipro Diabetes Systems, Inc.
Miramar, FL, US - Received
- June 13, 2007
- Decision date
- December 14, 2007
- 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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| 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 |
|---|---|---|
| K050312 | Amigo Insulin PumpLZG · Traditional | 05/09/2005SE |
| K014114 | Glucopro Syringe, Model Gpsy-XxxxxxxxFMF · Traditional | 06/26/2002SE |
| K013309 | Glucopro Evo Infusion PumpLZG · Traditional | 06/24/2002SE |
| K011120 | Glucopro Infusion Set, Model Gpisxxxxxxxx SeriesFPA · Traditional | 05/08/2001SE |
Questions and answers
When was Amigo Insulin Pump cleared by the FDA?
Amigo Insulin Pump (K071613) received a 510(k) decision of Substantially Equivalent on December 14, 2007, 184 days after the submission was received.
What is the product code of K071613?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.