510(k) · Cleared
Recalled · Class I · 2026Omnipod® Insulin Management System, Omnipod DASH® Insulin 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 Aug 13, 2021 as substantially equivalent to K192659 (Insulet Corporation, 2019) after an 84-day review. Its family tree reaches back 7 generations to 2005. 2 of the 8 devices in its family, counting itself, have a Class I recall. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Aug 13, 2021
- Review
- 84 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 3 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K042792 (2005). No later device cites it as a predicate yet. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK042792 Ixl-II Diabetes Management SystemInsulet Corporation · 2005
- 6 generations backK111669 Freestyle Glucose Meter Incorporated Into the Omnipod Insulin…Insulet Corporation · 2011
- 5 generations backK122953 Omnipod Insulin Managment SystemInsulet Corporation · 2012 · Recalled (Class I)
- 4 generations backK162296 OmniPod Insulin Management SystemInsulet Corporation · 2017
- 3 generations backK180045 Omnipod DASH Insulin Management SystemInsulet Corporation · 2018 · Recalled
- 2 generations backK182630 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019
- 1 generation backK192659 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019 · Recalled
- This deviceK211575 Omnipod® Insulin Management System, Omnipod DASH® Insulin Management…Insulet Corporation · 2021
Class I recalls in this family
- K122953 Omnipod Insulin Managment System4 generations back · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K042792 | Ixl-II Diabetes Management System | Insulet Corporation | 2005 | — |
| −6 | K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems | Insulet Corporation | 2011 | — |
| −5 | K122953 | Omnipod Insulin Managment System | Insulet Corporation | 2012 | Class I |
| −4 | K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017 | — |
| −3 | K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018 | 1 |
| −2 | K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | — |
| −1 | K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | 4 |
| 0 (this device) | K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemSummary page 5…0(k) Regulation Number: 880.5725 Device Class: Class II K192659 Omnipod Insulin Management Device predicate: System and Omnipod DASH Insulin… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2026 | Class I | Z-2604-2026 | Process design | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of… |
| May 20, 2026 | Class I | Z-2605-2026 | Process design | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of… |
| Oct 17, 2022 | Class I | Z-0154-2023 | Device Design | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal… |
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 · 4 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 PDM glucose meter is intended for single-patient use and should not be…
Read the full statement (175 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 PDM glucose meter is intended for 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.
The Omnipod DASH 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.
Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211575: Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211575
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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