510(k) · Cleared
Recalled · Class II · 2018Omnipod 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 Jun 1, 2018 as substantially equivalent to K162296 (Insulet Corporation, 2017) after a 144-day review. Its family tree reaches back 4 generations to 2005. 2 of the 8 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 1, 2018
- Review
- 144 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042792 (2005). 3 later devices descend from it, 1 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK042792 Ixl-II Diabetes Management SystemInsulet Corporation · 2005
- 3 generations backK111669 Freestyle Glucose Meter Incorporated Into the Omnipod Insulin…Insulet Corporation · 2011
- 2 generations backK122953 Omnipod Insulin Managment SystemInsulet Corporation · 2012 · Recalled (Class I)
- 1 generation backK162296 OmniPod Insulin Management SystemInsulet Corporation · 2017
- This deviceK180045 Omnipod DASH Insulin Management SystemInsulet Corporation · 2018
- Descendant · cites it directly · 2 of its ownK182630 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK192659 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK211575 Omnipod® Insulin Management System, Omnipod DASH® Insulin Management…Insulet Corporation · 2021 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation · 2019 · cites it directly2descendants
- K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation · 2019 · 2 generations on1descendant
- K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042792 | Ixl-II Diabetes Management System | Insulet Corporation | 2005 | — |
| −3 | K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems | Insulet Corporation | 2011 | — |
| −2 | K122953 | Omnipod Insulin Managment System | Insulet Corporation | 2012 | Class I |
| −1 | K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017 | — |
| 0 (this device) | K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018 | — |
| +1 | K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | — |
| +2 | K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | 4 |
| +3 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K162296 | OmniPod Insulin Management SystemSummary page 4…: BLE-I1-529 Model Number (PDM): USA1-D001-MG-USA1 Device Predicate: K162296 Omnipod® Insulin Management System Insulet Corporation… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | 2019 | 2 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2018 | Class II | Z-0347-2020 | Software design | There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history. |
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 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K182630 (Insulet Corporation, 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K162296.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K180045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180045: 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/K180045
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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