510(k) · Cleared
ClearedOmnipod GO Insulin Delivery Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insulet Corporation · LZG Pump, Infusion, Insulin
Cleared on Apr 24, 2023 as substantially equivalent to K103825 (Valeritas, Inc., 2011) after a 171-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Apr 24, 2023
- Review
- 171 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K031373 (2003). No later device cites it as a predicate yet.
- Root · 4 generations backK031373 Ixl Diabetes Management SystemInsulet Corp. · 2003
- 3 generations backK050971 Biovalve Insulin Delivery Systems (Bids)Biovalve Technologies, Inc. · 2005
- 2 generations backK100504 V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30…Valeritas, LLC · 2010
- 1 generation backK103825 V-GO Insulin Delivery SystemValeritas, Inc. · 2011 · Recalled
- This deviceK223372 Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031373 | Ixl Diabetes Management System | Insulet Corp. | 2003 | — |
| −3 | K050971 | Biovalve Insulin Delivery Systems (Bids) | Biovalve Technologies, Inc. | 2005 | — |
| −2 | 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 |
| 0 (this device) | K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023 | — |
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 |
|---|---|---|---|
| * | K103825 | V-GO Insulin Delivery SystemSummary page 4…Traditional 510(k) Regulation Numbers: 21 CFR 880.5725 Device Class: Class II Predicate device: K103825, V-GO Insulin Delivery System K211575, Omnipod DASH Insulin Reference device:… | 2011 |
| † | K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223372 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223372: Omnipod GO Insulin Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223372
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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