# K131294: Omnipod Insulin Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Aug 29, 2013 after 115 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 1.

## Indications for use
The OmnniPod® 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.

Source page: https://510kreport.com/device/K131294
Methodology: https://510kreport.com/methodology