Modification to Disetronic D-Tronplus Insulin Infusion Pump
by Disetronic Medical Systems AG 510(k)
Active
510(k) K022831
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022831 | Date11 Sep 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1198-03
Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
Specification
- 510(k) Number
- FDA Product Code
- LZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
This device is a modification to the Disetronic D-Tronplus Insulin Infusion Pump, which is an ambulatory, battery-operated pump designed for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin-dependent diabetes mellitus who do not have optimum blood glucose control on conventional insulin injection therapy.
The pump is compact, shock-resistant, and fulfills the requirements for IP X7. It is supplied as a reusable device and is authorized under FDA 510(k) clearance K022831, with device class 2 and product code LZG. The device is regulated for general hospital use and is manufactured by Disetronic Medical Systems AG.
Other devices from Disetronic Medical Systems
Questions
AI-generated answers, 27 Sep 2026
What is the Modification to Disetronic D-Tronplus Insulin Infusion Pump used for?
It is used for the controlled delivery of insulin as prescribed by a physician for patients with insulin-dependent diabetes mellitus who do not have optimum blood glucose control on conventional insulin injection therapy.
Is the Modification to Disetronic D-Tronplus Insulin Infusion Pump reusable or single-use?
The device is supplied as a reusable device, meaning it is designed for multiple uses over time under proper maintenance and handling, not for single-use disposal.
What regulatory authorization does the Modification to Disetronic D-Tronplus Insulin Infusion Pump have?
It is authorized under FDA 510(k) clearance K022831, with device class 2 and product code LZG, indicating it was found substantially equivalent to a legally marketed predicate device.