# K100504: V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40

- Pathway: 510(k) (Traditional)
- Applicant: Valeritas, LLC
- Decided: Dec 1, 2010 after 282 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: 2 generations back to K031373 (2003). 2 ancestors in all.
2 later devices descend 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)
- K050971: Biovalve Insulin Delivery Systems (Bids), Biovalve Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K103825: V-GO Insulin Delivery System (2011), 1 descendant of its own
- K223372: Omnipod GO Insulin Delivery Device (2023), 0 descendants of its own

## Indications for use
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 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 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

Source page: https://510kreport.com/device/K100504
Methodology: https://510kreport.com/methodology