510(k) · Cleared
ClearedFreestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems
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 15, 2011 as substantially equivalent to K042792 (Insulet Corporation, 2005) after a 183-day review. Its family tree reaches back 1 generation to 2005. 2 of the 11 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Dec 15, 2011
- Review
- 183 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042792 (2005). 9 later devices descend from it, 1 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK042792 Ixl-II Diabetes Management SystemInsulet Corporation · 2005
- This deviceK111669 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
- Descendant · 4 generations on · 1 of its ownK192659 Omnipod Insulin Management System, Omnipod DASH Insulin Management…Insulet Corporation · 2019 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- 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
- K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042792 | Ixl-II Diabetes Management System | Insulet Corporation | 2005 | — |
| 0 (this device) | 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 | — |
| +4 | K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K042792 | Ixl-II Diabetes Management System Our reading of the summary gave K042972, FDA’s number for XP Technology Ultrasonic Scaler (American Eagle Instruments, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “IXL-II System”. | 2005 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122953 | Omnipod Insulin Managment System Class I | 2012 | 8 |
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?
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 (129 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111669: Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111669
Report an extraction error
Are you the manufacturer?
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