# K111669: Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Dec 15, 2011 after 183 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 K042792 (2005). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042792: Ixl-II Diabetes Management System, Insulet Corporation (2005). Our reading of the summary gave K042972, FDA’s number for XP Technology Ultrasonic Scaler (American Eagle Instruments, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “IXL-II System”. Summary page 3.

## Most influential descendants
- 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
- K192659: Omnipod Insulin Management System, Omnipod DASH Insulin Management System (2019), 1 descendant of its own

## Indications for use
The OmniPod Insulin Management System is 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) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott FreeStyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.

Source page: https://510kreport.com/device/K111669
Methodology: https://510kreport.com/methodology