# K031373: Ixl Diabetes Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corp.
- Decided: Dec 19, 2003 after 233 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
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic MiniMed System, consisting of the 508 Insulin Pump, Reservoir, Sil-serter Infusion Set Insertion System, and the Silhouette Infusion Set: named in the summary without a submission number

## Most influential descendants
- K050971: Biovalve Insulin Delivery Systems (Bids) (2005), 10 descendants of its own
- K093065: Finesse Personal Insulin Delivery Patch, Model FG-2000 (2010), 6 descendants of its own
- K100947: Finesse Personal Insulin Delivery Patch, Model FG 2000 (2010), 5 descendants of its own
- K111924: Finesse Personal Insulin Delivery Patch (2012), 4 descendants of its own
- K163357: OneTouch Via On-Demand Insulin Delivery System (2017), 3 descendants of its own

## Indications for use
For the continuous, subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K031373
Methodology: https://510kreport.com/methodology