510(k) · Cleared
Recalled · Class II · 2012Model IR 1200 Insulin 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 Oct 16, 2003 after an 86-day review. The FDA summary names its predicate without a number. 1 of the 44 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 16, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 7
- Predicates
- 0
43 later devices descend from it, 2 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- This deviceK032257 Model IR 1200 Insulin PumpAnimas Corp. · 2003
- Descendant · cites it directly · 39 of its ownK042887 Accu-Chek SpiritDisetronic Medical Systems AG · 2005 · Recalled
- Descendant · 2 generations on · 38 of its ownK060876 Accu-Chek Insulin Pump Configuration Software (Standard), Model…Disetronic Medical Systems AG · 2006 · Recalled
- Descendant · 3 generations on · 37 of its ownK111353 Accu-Check Combo SystemRoche Diagnostics · 2012 · Recalled
- Descendant · 4 generations on · 33 of its ownK141929 Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · Recalled
- Descendant · 5 generations on · 32 of its ownK150910 ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology8 generations on · 2020
Most influential descendants
Showing 5 of 43 · See all- K042887Accu-Chek SpiritDisetronic Medical Systems AG · 2005 · cites it directly39descendants
- K060876Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek…Disetronic Medical Systems AG · 2006 · 2 generations on38descendants
- K111353Accu-Check Combo SystemRoche Diagnostics · 2012 · 3 generations on37descendants
- K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 2015 · 4 generations on33descendants
- K150910ACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc. · 2015 · 5 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032257 | Model IR 1200 Insulin Pump | Animas Corp. | 2003 | — |
| +1 | K042887 | Accu-Chek Spirit | Disetronic Medical Systems AG | 2005 | 1 |
| +2 | K060876 | Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001… | Disetronic Medical Systems AG | 2006 | 1 |
| +3 | K111353 | Accu-Check Combo System | Roche Diagnostics | 2012 | 3 |
| +4 | K141929 | Accu-Chek Connect Diabetes Management App | Roche Diagnostics Corporation | 2015 | 1 |
| +5 | K150910 | ACCU-CHEK Connect Diabetes Management App | Roche Diabetes Care, Inc. | 2015 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 5 | 1 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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.
1 device in this family has 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 16.9 · 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 IR 1000 Series Insulin Infusion Pump Named without a submission number |
What descends from it? (43)
See all 432 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Jul 16, 2012 | Class II | Z-0005-2013 | Nonconforming Material/Component | Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. |
| Feb 25, 2011 | Not classified | Z-1678-2011 | Material/Component Contamination | Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking. |
| Mar 18, 2010 | Not classified | Z-2396-2010 | Equipment maintenance | sensor could be damaged |
| Aug 4, 2008 | Not classified | Z-0293-2009 | 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-0308-06 | Other | Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. |
| Sep 28, 2004 | Not classified | Z-0211-05 | Other | Suspend mode not functioning properly |
The 5 latest of 7 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.
- K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042887 (Disetronic Medical Systems AG, 2005) has gone furthest, with 39 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 Model IR 1200 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.
This device is intended for home use and is a prescription device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032257 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032257: Model IR 1200 Insulin Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032257
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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