# K905693: H-Tron V 100 Insulin Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Disetronic Medical Systems
- Decided: Apr 12, 1991 after 114 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
No predicates in its family tree.
28 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973044: Disetronic H-Tron Plus V 100 Insulin Infusion Pump (1997), 27 descendants of its own
- 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

## Recalls of this device
- Jul 21, 2003 · Not classified · Z-1196-03: Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

Source page: https://510kreport.com/device/K905693
Methodology: https://510kreport.com/methodology