# K223372: Omnipod GO Insulin Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Apr 24, 2023 after 171 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: 4 generations back to K031373 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103825: V-GO Insulin Delivery System, Valeritas, Inc. (2011) Summary page 4.

## Indications for use
The Omnipod GO Insulin Delivery Device is intended for the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes.

Source page: https://510kreport.com/device/K223372
Methodology: https://510kreport.com/methodology