510(k) · Cleared
ClearedIxl-II Diabetes Management System
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 Jan 3, 2005 after an 89-day review. The FDA summary names its predicate without a number. 2 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.
- Decided
- Jan 3, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 6 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- This deviceK042792 Ixl-II Diabetes Management SystemInsulet Corporation · 2005
- Descendant · cites it directly · 9 of its ownK111669 Freestyle Glucose Meter Incorporated Into the Omnipod Insulin…Insulet Corporation · 2011
- Descendant · cites it directly · 8 of its ownK122953 Omnipod Insulin Managment SystemInsulet Corporation · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK162296 OmniPod Insulin Management SystemInsulet Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK180045 Omnipod DASH Insulin Management SystemInsulet Corporation · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK182630 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K111669Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management SystemsInsulet Corporation · 2011 · cites it directly9descendants
- K122953Omnipod Insulin Managment SystemInsulet Corporation · 2012 · cites it directly8descendants
- K162296OmniPod Insulin Management SystemInsulet Corporation · 2017 · 2 generations on4descendants
- K180045Omnipod DASH Insulin Management SystemInsulet Corporation · 2018 · 3 generations on3descendants
- K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042792 | Ixl-II Diabetes Management System | Insulet Corporation | 2005 | — |
| +1 | K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems | Insulet Corporation | 2011 | — |
| +1 | K122953 | Omnipod Insulin Managment System | Insulet Corporation | 2012 | Class I |
| +2 | K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017 | — |
| +3 | K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018 | 1 |
| +3 | K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | — | iXL Diabetes Management System Named without a submission number | |
| * | — | TheraSense FreeStyle Blood Glucose Monitor Named without a submission number |
What descends from it? (15)
See all 156 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems | 2011 | 9 |
| K122953 | Omnipod Insulin Managment System Class I | 2012 | 8 |
| K080639 | Symphony Glucose Management System | 2008 | 2 |
| K090245 | Solo Insulin Patch Pump | 2009 | 1 |
| K093364 | Solo Micropump Insulin Delivery System | 2010 | 0 |
| K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System | 2009 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122953Omnipod Insulin Managment SystemInsulet Corporation · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 14 Class I recalls
- K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K111669 (Insulet Corporation, 2011) has gone furthest, with 9 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.
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?
Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042792 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042792: Ixl-II Diabetes Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042792
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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