# K051041: Insulin Pump

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Dec 23, 2005 after 242 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: 1 generation back to K040676 (2004). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040676: Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715, Medtronic Minimed (2004) Summary page 1.

## Most influential descendants
- K071788: Aviator Insulin Pump (2008), 1 descendant of its own
- K083225: Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System (2009), 0 descendants of its own

## Indications for use
The Insulin Pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K051041
Methodology: https://510kreport.com/methodology