# K994186: Disetronic D-Tron Insulin Infusion Pump

- Pathway: 510(k) (Special)
- Applicant: Disetronic Medical Systems
- Decided: Dec 30, 1999 after 20 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905693 (1991). 2 ancestors in all.
6 later devices descend from it; 3 cite 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)
- K973044: Disetronic H-Tron Plus V 100 Insulin Infusion Pump, Disetronic Medical Systems (1997). Our OCR of the scanned summary read K873044, FDA’s number for Porex Otology Instruments (Porex Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Disetronic H-TRON Plus V100 Insulin Infusion Pump”.

## Most influential descendants
- K021725: Disetronic D-Tron Insulin Infusion Pump (2002), 5 descendants of its own
- K022831: Modification to Disetronic D-Tronplus Insulin Infusion Pump (2002), 4 descendants of its own
- K043000: Modification to D-Tronplus (2004), 3 descendants of its own
- K100567: Pearl Diabetes Management System (2011), 2 descendants of its own
- K122483: Pearl Diabetes Management System (2013), 1 descendant of its own

## Indications for use
The Disetronic D-TRON Insulin Infusion Pump is intended 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. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis, as well as adhere to a proper diet and exercise regiment. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

Source page: https://510kreport.com/device/K994186
Methodology: https://510kreport.com/methodology