# K083225: Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Feb 20, 2009 after 109 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: 9 generations back to K945887 (1995). 42 ancestors in all.
No later device cites it as a predicate yet.
1 of 43 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080639: Symphony Glucose Management System, Animas Corp. (2008) Summary page 1.
- K042792: Ixl-II Diabetes Management System, Insulet Corporation (2005) Summary page 1.
- K071788: Aviator Insulin Pump, Abbott Diabetes Care, Inc. (2008) Summary page 1.
- K070850: Freestyle Lite Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2007) Summary page 1.

## Indications for use
The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only.

Source page: https://510kreport.com/device/K083225
Methodology: https://510kreport.com/methodology