# K973044: Disetronic H-Tron Plus V 100 Insulin Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Sep 15, 1997 after 31 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905693 (1991). 1 ancestor in all.
27 later devices descend from it; 5 cite it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905693: H-Tron V 100 Insulin Infusion Pump, Disetronic Medical Systems (1991) Summary page 1.

## Most influential descendants
- K013309: Glucopro Evo Infusion Pump (2002), 12 descendants of its own
- K050312: Amigo Insulin Pump (2005), 11 descendants of its own
- K071613: Amigo Insulin Pump (2007), 10 descendants of its own
- K111210: T:Slim (TM) Insulin Delivery System (2011), 9 descendants of its own
- K133593: T:Slim Insulin Delivery System (2014), 8 descendants of its own

## Recalls of this device
- May 17, 2004 · Not classified · Z-1225-04: Lack of assurance of sterility.
- May 17, 2004 · Not classified · Z-1226-04: Lack of assurance of sterility.
- May 17, 2004 · Not classified · Z-1222-04: Lack of assurance of sterility.
- May 17, 2004 · Not classified · Z-1224-04: Lack of assurance of sterility.
- May 17, 2004 · Not classified · Z-1223-04: Lack of assurance of sterility.

## Indications for use
The Disetronic H-TRON V 100 Plus 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/K973044
Methodology: https://510kreport.com/methodology