# K042792: Ixl-II Diabetes Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Jan 3, 2005 after 89 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.
15 later devices descend from it; 6 cite it directly.
2 of 16 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) iXL Diabetes Management System: named in the summary without a submission number
- (no number) TheraSense FreeStyle Blood Glucose Monitor: named in the summary without a submission number

## Most influential descendants
- K111669: Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems (2011), 9 descendants of its own
- K122953: Omnipod Insulin Managment System (2012), 8 descendants of its own
- K162296: OmniPod Insulin Management System (2017), 4 descendants of its own
- K180045: Omnipod DASH Insulin Management System (2018), 3 descendants of its own
- K182630: Omnipod Insulin Management System, Omnipod DASH Insulin Management System (2019), 2 descendants of its own

## Indications for use
Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).

Source page: https://510kreport.com/device/K042792
Methodology: https://510kreport.com/methodology