# K140439: Omnipod Insulin Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Nov 13, 2014 after 265 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.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122953: Omnipod Insulin Managment System, Insulet Corporation (2012) Summary page 4.

## Indications for use
The OmniPod® Insulin Management System is intended for subcutaneous (below the skin) 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 capillary whole blood (in vitro) from the fingertip. The glucose measurements should not be used for the diagnosis of or screening for diabetes or for neonatal use. The PDM glucose meter is intended for single-patient use and should not be shared. OneTouch® Verio™ Test Strips are used with the built-in blood glucose meter with One Touch Verio technology for the quantitative measurement of blood glucose in fresh capillary whole blood drawn from the fingertips. OneTouch Verio Control Solutions are used to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K140439
Methodology: https://510kreport.com/methodology