# K103825: V-GO Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Valeritas, Inc.
- Decided: Feb 23, 2011 after 55 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K031373 (2003). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100504: V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40, Valeritas, LLC (2010) Summary page 1.

## Most influential descendants
- K223372: Omnipod GO Insulin Delivery Device (2023), 0 descendants of its own

## Recalls of this device
- Jul 3, 2019 · Class II · Z-0195-2020: There is a potential for "No Needle Demo Units" to contain a needle.
- Jul 3, 2019 · Class II · Z-0199-2020: There is a potential for "No Needle Demo Units" to contain a needle.
- Jul 3, 2019 · Class II · Z-0196-2020: There is a potential for "No Needle Demo Units" to contain a needle.
- Jul 3, 2019 · Class II · Z-0197-2020: There is a potential for "No Needle Demo Units" to contain a needle.
- Jul 3, 2019 · Class II · Z-0198-2020: There is a potential for "No Needle Demo Units" to contain a needle.

## Indications for use
The V-Go 20 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24-hour time period (0.83U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin The V-Go 30 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24-hour time period (1.25U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin The V-Go 40 Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24-hour time period (1.67U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin

Source page: https://510kreport.com/device/K103825
Methodology: https://510kreport.com/methodology