# K050312: Amigo Insulin Pump

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Diabetes Systems, Inc.
- Decided: May 9, 2005 after 90 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: 3 generations back to K901588 (1990). 5 ancestors in all.
11 later devices descend from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013309: Glucopro Evo Infusion Pump, Nipro Diabetes Systems, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K141758: T:Slim Insulin Delivery System (2014), 7 descendants of its own
- K160056: t:slim Insulin Delivery System (2016), 4 descendants of its own

## Indications for use
The Amigo Infusion Pump is intended for the subcutaneous infusion of insulin

Source page: https://510kreport.com/device/K050312
Methodology: https://510kreport.com/methodology