510(k) · Cleared
Recalled · Class II · 2026Medtronic Minimed Paradigm Insulin Pump, Model MMT-712
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minimed, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Jul 23, 2003 after an 82-day review. The FDA summary names its predicate without a number. 1 of the 41 devices in its family, counting itself, has a Class I recall. 40 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- 2
- Predicates
- 0
40 later devices descend from it, 1 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- This deviceK031390 Medtronic Minimed Paradigm Insulin Pump, Model MMT-712Minimed, Inc. · 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 40 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 40 · 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) | K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712 | Minimed, Inc. | 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 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 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 LGZ device
- #1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 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 |
|---|---|---|---|
| * | — | Medtronic MiniMed Paradigm Model 511 Insulin Pump Named without a submission number |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042887 | Accu-Chek Spirit | 2005 | 39 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2026 | Class II | Z-1748-2026 | Device Design | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site… |
| Apr 27, 2007 | Not classified | Z-1007-2007 | Other | Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage… |
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 LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGZ
546in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGZ
376in 2025
MAUDE reports naming product code LGZ, 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 | 2 | — | 0 | 11 |
| 2008 | 4 | 99 | 0 | 10 |
| 2009 | 2 | — | 1 | 12 |
| 2010 | 2 | — | 1 | 43 |
| 2011 | 3 | 77 | 8 | 54 |
| 2012 | 7 | 162 | 0 | 52 |
| 2013 | 5 | 143 | 0 | 16 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 2 | — | 1 | 34 |
| 2016 | 2 | — | 1 | 15 |
| 2017 | 2 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 94 |
| 2019 | 3 | 209 | 0 | 340 |
| 2020 | 0 | — | 0 | 1,221 |
| 2021 | 0 | — | 0 | 885 |
| 2022 | 3 | 546 | 0 | 1,548 |
| 2023 | 1 | — | 0 | 1,033 |
| 2024 | 1 | — | 0 | 862 |
| 2025 | 2 | — | 0 | 376 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Medtronic MiniMed Paradigm Model 712 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for thc management of diabetes mellitus in persons requiring insulin.
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/K031390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031390: Medtronic Minimed Paradigm Insulin Pump, Model MMT-712.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031390
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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