510(k) · Cleared
Recalled · Class I · 2015Omnipod Insulin Managment 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 Dec 7, 2012 as substantially equivalent to K111669 (Insulet Corporation, 2011) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 2005. 2 of the 11 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 8 times, including 4 Class I recalls.
- Decided
- Dec 7, 2012
- Review
- 73 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 8 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K042792 (2005). 8 later devices descend from it, 4 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK042792 Ixl-II Diabetes Management SystemInsulet Corporation · 2005
- 1 generation backK111669 Freestyle Glucose Meter Incorporated Into the Omnipod Insulin…Insulet Corporation · 2011
- This deviceK122953 Omnipod Insulin Managment SystemInsulet Corporation · 2012
- Descendant · cites it directly · 4 of its ownK162296 OmniPod Insulin Management SystemInsulet Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK180045 Omnipod DASH Insulin Management SystemInsulet Corporation · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK182630 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019
- Descendant · 3 generations on · 1 of its ownK192659 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK211575 Omnipod® Insulin Management System, Omnipod DASH® Insulin Management…Insulet Corporation · 2021 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211575 Omnipod® Insulin Management System, Omnipod…4 generations on · 2021
Most influential descendants
Showing 5 of 8 · See all- K162296OmniPod Insulin Management SystemInsulet Corporation · 2017 · cites it directly4descendants
- K180045Omnipod DASH Insulin Management SystemInsulet Corporation · 2018 · 2 generations on3descendants
- K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation · 2019 · 2 generations on2descendants
- K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation · 2019 · 3 generations on1descendant
- K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042792 | Ixl-II Diabetes Management System | Insulet Corporation | 2005 | — |
| −1 | K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems | Insulet Corporation | 2011 | — |
| 0 (this device) | K122953 | Omnipod Insulin Managment System | Insulet Corporation | 2012 | — |
| +1 | K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017 | — |
| +2 | K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018 | 1 |
| +2 | K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | — |
| +3 | K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | 4 |
| +4 | K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | 2021 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management SystemsSummary page 1…2 Model number (Pod/b -pack): ZXP425 Model number (PDM): 14500-5A (UST400 Series) Device predicate: K1 11669 - FreeStyle® Glucose Meter incorporated into the OmniPod Insulin Management Systems… | 2011 |
| * | K042792 | Ixl-II Diabetes Management SystemSummary page 1…669 - FreeStyle® Glucose Meter incorporated into the OmniPod Insulin Management Systems K042792 - iXL-II Diabetes Management System Insulet Corporation… | 2005 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2015 | Class I | Z-0393-2016 | Process change control | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. |
| Nov 2, 2015 | Class I | Z-0394-2016 | Process change control | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. |
| Jul 19, 2015 | Class II | Z-2749-2015 | Packaging | Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination. |
| Jul 19, 2015 | Class II | Z-2748-2015 | Packaging | Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination. |
| Jul 13, 2015 | Class I | Z-2485-2015 | Nonconforming Material/Component | OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin |
| Jul 13, 2015 | Class I | Z-2484-2015 | Nonconforming Material/Component | OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin |
| Sep 27, 2013 | Class II | Z-0166-2014 | Labeling design | Alcohol Prep Pads contained within the kit are not properly labeled. |
| Sep 27, 2013 | Class II | Z-0165-2014 | Labeling design | Alcohol Prep Pads contained within the kit are not properly labeled. |
The 5 latest of 8 recalls; the web page lists all.
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.
- K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162296 (Insulet Corporation, 2017) has gone furthest, with 4 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. 2012, 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 Insulin Management System is 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) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The POM glucose meter is intended far single-patient use and should not be…
Read the full statement (128 words)
The OmniPod Insulin Management System is 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) from the finger.
The glucose measurements should not be used for the diagnosis of or screening for diabetes. The POM glucose meter is intended far single-patient use and should not be shared.
Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122953: Omnipod Insulin Managment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122953
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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