# K013309: Glucopro Evo Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Diabetes Systems, Inc.
- Decided: Jun 24, 2002 after 263 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 K901588 (1990). 4 ancestors in all.
12 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)
- K973044: Disetronic H-Tron Plus V 100 Insulin Infusion Pump, Disetronic Medical Systems (1997) Summary page 1.
- K960001: Minimed Infusion Pump, Model MMT-507, Medtronic Minimed (1996) Summary page 1.

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

## Recalls of this device
- May 7, 2004 · Not classified · Z-1335-04: A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.

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

Source page: https://510kreport.com/device/K013309
Methodology: https://510kreport.com/methodology