# K162296: OmniPod Insulin Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Apr 18, 2017 after 245 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: 3 generations back to K042792 (2005). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122953: Omnipod Insulin Managment System, Insulet Corporation (2012) Summary page 5.

## Most influential descendants
- 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
- K211575: Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (2021), 0 descendants 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/K162296
Methodology: https://510kreport.com/methodology