# K043000: Modification to D-Tronplus

- Pathway: 510(k) (Special)
- Applicant: Disetronic Medical Systems AG
- Decided: Dec 1, 2004 after 30 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K905693 (1991). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022831: Modification to Disetronic D-Tronplus Insulin Infusion Pump, Disetronic Medical Systems AG (2002)

## Most influential descendants
- K100567: Pearl Diabetes Management System (2011), 2 descendants of its own
- K122483: Pearl Diabetes Management System (2013), 1 descendant of its own
- K142619: Snap Insulin Pump System (2014), 0 descendants of its own

## Recalls of this device
- Jul 13, 2006 · Not classified · Z-1413-06: The battery may turn the pump off without warning due to a design change in the battery.
- Jul 15, 2005 · Not classified · Z-1105-05: The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.

## Indications for use
The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Dlabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.

Source page: https://510kreport.com/device/K043000
Methodology: https://510kreport.com/methodology