# K991376: Dahedi Insulin Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Jun 15, 1999 after 55 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 3 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) Summary page 1.

## Recalls of this device
- Jul 28, 2003 · Not classified · Z-1244-03: Lack of assurance of reliability.

## Indications for use
The DAHEDI insulin Infusion Pump is intended for the controlied 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/K991376
Methodology: https://510kreport.com/methodology