Accu-Chek Spirit
FDA 510(k) K042887 · Disetronic Medical Systems AG
510(k) numberK042887
Submission
- Device name
- Accu-Chek Spirit
- Applicant
- Disetronic Medical Systems AG
Burgdorf, CH - Received
- October 19, 2004
- Decision date
- March 18, 2005
- 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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| 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 |
|---|---|---|
| K100704 | Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion DeviceFRN · Special | 05/14/2010SE |
| K070189 | Accu-Chek Ultraflex Infusion SetFPA · Special | 02/21/2007SE |
| K063146 | Accu-Chek LinkassistKZH · Traditional | 11/27/2006SE |
| K060876 | Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek…LZG · Traditional | 06/15/2006SE |
| K043000 | Modification to D-TronplusLZG · Special | 12/01/2004SE |
| K033892 | Ultraflex Infusion SetFPA · Traditional | 03/09/2004SE |
| K023471 | Disetronic H-Tronplus Insulin Infusion PumpLZG · Special | 10/29/2002SE |
| K022831 | Modification to Disetronic D-Tronplus Insulin Infusion PumpLZG · Special | 09/11/2002SE |
| K021725 | Disetronic D-Tron Insulin Infusion PumpLZG · Special | 08/02/2002SE |
| K013782 | Disetronic Penfine Insulin Injection Pen NeedleFMI · Traditional | 11/20/2001SE |
Questions and answers
When was Accu-Chek Spirit cleared by the FDA?
Accu-Chek Spirit (K042887) received a 510(k) decision of Substantially Equivalent on March 18, 2005, 150 days after the submission was received.
What is the product code of K042887?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.