Disetronic D-Tron Insulin Infusion Pump
FDA 510(k) K994186 · Disetronic Medical Systems
510(k) numberK994186
Submission
- Device name
- Disetronic D-Tron Insulin Infusion Pump
- Applicant
- Disetronic Medical Systems
Fort Myers, FL, US - Received
- December 10, 1999
- Decision date
- December 30, 1999
- 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
Other 510(k)s with product code LZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| 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 |
| K042887 | Accu-Chek SpiritLZG · Traditional | 03/18/2005SE |
| 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 |
Questions and answers
When was Disetronic D-Tron Insulin Infusion Pump cleared by the FDA?
Disetronic D-Tron Insulin Infusion Pump (K994186) received a 510(k) decision of Substantially Equivalent on December 30, 1999, 20 days after the submission was received.
What is the product code of K994186?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.