510(k) · Cleared
ClearedSolo Insulin Patch Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medingo, Ltd. · LZG Pump, Infusion, Insulin
Cleared on Jul 23, 2009 as substantially equivalent to K031373 (Insulet Corp., 2003) and 2 other predicates after a 171-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Jul 23, 2009
- Review
- 171 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K031373 (2003). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K093364Solo Micropump Insulin Delivery SystemMedingo, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031373 | Ixl Diabetes Management System | Insulet Corp. | 2003 | — |
| 0 (this device) | K090245 | Solo Insulin Patch Pump | Medingo, Ltd. | 2009 | — |
| +1 | K093364 | Solo Micropump Insulin Delivery System | Medingo, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K031373 | Ixl Diabetes Management SystemSummary page 1…d by the General Hospital panel. Predicate Devices: > iXL Diabetes Management System (Insulet Corp.), product code LZG, cleared for marketing under K03 1373, K042792 Solo TM Insulin Patch Pump - Page 5-2 > Paradigm Model 515 (Medtronic Mini… | 2003 |
| * | K042792 | Ixl-II Diabetes Management SystemSummary page 1…eneral Hospital panel. Predicate Devices: > iXL Diabetes Management System (Insulet Corp.), product code LZG, cleared for marketing under K03 1373, K042792 Solo TM Insulin Patch Pump - Page 5-2 > Paradigm Model 515 (Medtronic Minimed), pro… | 2005 |
| * | K073356 | Paradigm Insulin Infusion Pump, Models MMT-512, MMT-712, MMT-515 and MMT-715Summary page 2…Solo TM Insulin Patch Pump - Page 5-2 > Paradigm Model 515 (Medtronic Minimed), product code LZG, cleared for marketing under K073356. Intended Use: The Solo TM Insulin Patch Pump is intended for the continuous delivery of insulin, at set and variable rates, fo… | 2008 |
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 |
|---|---|---|---|
| K093364 | Solo Micropump Insulin Delivery System | 2010 | 0 |
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?
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Solo TM Insulin Patch Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090245: Solo Insulin Patch Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090245
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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