# K071613: Amigo Insulin Pump

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Diabetes Systems, Inc.
- Decided: Dec 14, 2007 after 184 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: 4 generations back to K901588 (1990). 8 ancestors in all.
10 later devices descend from it; 1 cites it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042873: Animas Model IR1250 Insulin Infusion Pump, Animas Corp. (2004) Summary page 1.
- K050312: Amigo Insulin Pump, Nipro Diabetes Systems, Inc. (2005) Summary page 1.
- K062323: Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817, Smiths Medical MD, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K240158: Modular Medical MODD1 Insulin Delivery System (2024), 2 descendants of its own

## Indications for use
The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin.

Source page: https://510kreport.com/device/K071613
Methodology: https://510kreport.com/methodology