510(k) · Cleared
ClearedV-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valeritas, LLC · LZG Pump, Infusion, Insulin
Cleared on Dec 1, 2010 as substantially equivalent to K050971 (Biovalve Technologies, Inc., 2005) after a 282-day review. Its family tree reaches back 2 generations to 2003. 2 later devices descend from it.
- Decided
- Dec 1, 2010
- Review
- 282 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031373 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK031373 Ixl Diabetes Management SystemInsulet Corp. · 2003
- 1 generation backK050971 Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 2005
- This deviceK100504 V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30…Valeritas, LLC · 2010
- Descendant · cites it directly · 1 of its ownK103825 V-GO Insulin Delivery SystemValeritas, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK223372 Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031373 | Ixl Diabetes Management System | Insulet Corp. | 2003 | — |
| −1 | K050971 | Biovalve Insulin Delivery Systems (Bids) | Biovalve Technologies, Inc. | 2005 | — |
| 0 (this device) | K100504 | V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40 | Valeritas, LLC | 2010 | — |
| +1 | K103825 | V-GO Insulin Delivery System | Valeritas, Inc. | 2011 | 5 |
| +2 | K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZG device
- #1 K253534 Pivot Insulin Delivery Systemscore 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050971 | Biovalve Insulin Delivery Systems (Bids)Summary page 1…o Disposable Insulin Delivery Device is substantially equivalent to the BioValye Insulin Delivery System (BIDS) K050971, cleared by this Center on 16 August 2005 Device Description: The Valeritas V-Go Disposable Insulin Delivery Device is… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103825 | V-GO Insulin Delivery System | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K103825 (Valeritas, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K050971.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZG
116in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZG
1in 2022
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · LZG
12,004in 2025
MAUDE reports naming product code LZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 112 | 1 | 5,110 |
| 2008 | 6 | 129 | 13 | 5,711 |
| 2009 | 2 | — | 2 | 9,471 |
| 2010 | 2 | — | 4 | 10,175 |
| 2011 | 4 | 189 | 2 | 12,858 |
| 2012 | 3 | 73 | 4 | 18,367 |
| 2013 | 2 | — | 3 (1) | 30,059 |
| 2014 | 4 | 123 | 2 (1) | 49,188 |
| 2015 | 1 | — | 2 (2) | 69,136 |
| 2016 | 4 | 116 | 0 | 56,581 |
| 2017 | 1 | — | 0 | 44,472 |
| 2018 | 1 | — | 3 (2) | 32,652 |
| 2019 | 2 | — | 5 | 29,027 |
| 2020 | 0 | — | 0 | 32,588 |
| 2021 | 1 | — | 0 | 31,522 |
| 2022 | 1 | — | 1 (1) | 28,225 |
| 2023 | 1 | — | 0 | 21,972 |
| 2024 | 2 | — | 0 | 18,228 |
| 2025 | 0 | — | 0 | 12,004 |
| 2026 | 2 | — | 2 (2) | — |
What is it indicated for?
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…
Read the full statement (135 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100504: V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100504
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026