510(k) · Cleared
Recalled · Class I · 2013Animas Model IR1250 Insulin Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Animas Corp. · LZG Pump, Infusion, Insulin
Cleared on Dec 10, 2004 after a 53-day review. The FDA summary names its predicate without a number. 2 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 6 times, including a Class I recall.
- Decided
- Dec 10, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 6 (1 Class I)
- Predicates
- 0
31 later devices descend from it, 3 citing it directly. 2 of the 32 devices in this family, counting this one, have a Class I recall.
- This deviceK042873 Animas Model IR1250 Insulin Infusion PumpAnimas Corp. · 2004
- Descendant · cites it directly · 16 of its ownK061110 Glucommander PlusCollaborativemed, LLC · 2006
- Descendant · 2 generations on · 13 of its ownK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
- Descendant · 3 generations on · 12 of its ownK113853 G+ SystemGlytec, LLC · 2012
- Descendant · cites it directly · 10 of its ownK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
- Descendant · 2 generations on · 9 of its ownK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K111210 T:Slim (TM) Insulin Delivery System2 generations on · 2011
Most influential descendants
Showing 5 of 31 · See all- K061110Glucommander PlusCollaborativemed, LLC · 2006 · cites it directly16descendants
- K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010 · 2 generations on13descendants
- K113853G+ SystemGlytec, LLC · 2012 · 3 generations on12descendants
- K071613Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007 · cites it directly10descendants
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042873 | Animas Model IR1250 Insulin Infusion Pump | Animas Corp. | 2004 | — |
| +1 | K061110 | Glucommander Plus | Collaborativemed, LLC | 2006 | — |
| +2 | K101344 | G+ System | Glytec, LLC (Formally Known AS Glucotec, Inc.) | 2010 | — |
| +3 | K113853 | G+ System | Glytec, LLC | 2012 | — |
| +1 | K071613 | Amigo Insulin Pump | Nipro Diabetes Systems, Inc. | 2007 | — |
| +2 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 0 |
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 |
|---|---|---|---|
| * | — | Animas Model IR1200 Insulin Infusion Pump Named without a submission number |
What descends from it? (31)
See all 313 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 |
|---|---|---|---|---|
| Jan 3, 2013 | Class I | Z-0993-2013 | Nonconforming Material/Component | Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime… |
| Dec 17, 2012 | Class III | Z-0836-2013 | Device Design | Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display. |
| Aug 4, 2008 | Not classified | Z-0294-2009 | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure… |
| Aug 4, 2008 | Not classified | Z-0292-2009 | Nonconforming Material/Component | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure… |
| Oct 31, 2005 | Not classified | Z-0309-06 | Other | Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. |
| Apr 11, 2005 | Not classified | Z-0929-05 | Other | pump failed to respond to keypad button pressess after using the food database feature |
The 5 latest of 6 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.
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K061110 (Collaborativemed, LLC, 2006) has gone furthest, with 16 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?
The Animas Model IR1250 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042873: Animas Model IR1250 Insulin Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042873
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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