510(k) · Cleared
Recalled · Class II · 2019V-GO Insulin Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valeritas, Inc. · LZG Pump, Infusion, Insulin
Cleared on Feb 23, 2011 as substantially equivalent to K100504 (Valeritas, LLC, 2010) after a 55-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Feb 23, 2011
- Review
- 55 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K031373 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK031373 Ixl Diabetes Management SystemInsulet Corp. · 2003
- 2 generations backK050971 Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 2005
- 1 generation backK100504 V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30…Valeritas, LLC · 2010
- This deviceK103825 V-GO Insulin Delivery SystemValeritas, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK223372 Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031373 | Ixl Diabetes Management System | Insulet Corp. | 2003 | — |
| −2 | K050971 | Biovalve Insulin Delivery Systems (Bids) | Biovalve Technologies, Inc. | 2005 | — |
| −1 | K100504 | V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40 | Valeritas, LLC | 2010 | — |
| 0 (this device) | K103825 | V-GO Insulin Delivery System | Valeritas, Inc. | 2011 | — |
| +1 | K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K100504 | V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40Summary page 1…elivery Device is substantially equivalent to the Valeritas V-Go Disposable Insulin Delivery Device K 100504, cleared by this Center on December 1, 2010 Device Description: The Valeritas… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223372 | Omnipod GO Insulin Delivery Device | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2019 | Class II | Z-0195-2020 | Employee error | There is a potential for "No Needle Demo Units" to contain a needle. |
| Jul 3, 2019 | Class II | Z-0199-2020 | Employee error | There is a potential for "No Needle Demo Units" to contain a needle. |
| Jul 3, 2019 | Class II | Z-0196-2020 | Employee error | There is a potential for "No Needle Demo Units" to contain a needle. |
| Jul 3, 2019 | Class II | Z-0197-2020 | Employee error | There is a potential for "No Needle Demo Units" to contain a needle. |
| Jul 3, 2019 | Class II | Z-0198-2020 | Employee error | There is a potential for "No Needle Demo Units" to contain a needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K223372 (Insulet Corporation, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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…
Read the full statement (135 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103825: V-GO Insulin Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103825
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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