510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715

K040676510(k) TraditionalCleared May 21, 200467-day reviewClass II21 CFR 880.5725Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Minimed · LZG Pump, Infusion, Insulin

Cleared on May 21, 2004 after a 67-day review. The FDA summary names its predicate without a number. 20 later devices descend from it. It has been recalled 2 times.

Decided
May 21, 2004
Review
67 days
Class
Class II
Product code
LZG
Recalls
2
Predicates
0

20 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2005: 1 descendant cleared2008: 2 descendants cleared2010: 1 descendant cleared2007: 1 descendant cleared2014: 2 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2017: 2 descendants cleared2015: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK040676 Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715Medtronic Minimed · 2004
  2. Descendant · cites it directly · 16 of its ownK061110 Glucommander PlusCollaborativemed, LLC · 2006
  3. Descendant · 2 generations on · 13 of its ownK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
  4. Descendant · 3 generations on · 12 of its ownK113853 G+ SystemGlytec, LLC · 2012
  5. Descendant · 4 generations on · 8 of its ownK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
  6. Descendant · 5 generations on · 3 of its ownK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 22009: 12010: 12012: 12014: 22015: 12017: 22018: 12020: 22021: 12024: 12026: 2
2005high 2 (2008) · low 0 (2011)2026

Most influential descendants

Showing 5 of 20 · 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
  • K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · 4 generations on8descendants
  • K200443EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040676Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715Medtronic Minimed2004—
+1K061110Glucommander PlusCollaborativemed, LLC2006—
+2K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)2010—
+3K113853G+ SystemGlytec, LLC2012—
+4K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies20141
+5K200443EndoTool IV 1.10Monarch Medical Technologies, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200820
200910
201010
201210
201420
201510
201720
201810
202020
202110
202410
202620
FIG. 1 — Lineage of K040676, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in LZG? 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. #1 K253534 Pivot Insulin Delivery Systemscore 16.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Medtronic MiniMed Paradigm Model 512 Insulin Pump
Named without a submission number
—
*—Medtronic MiniMed Paradigm Model 712 Insulin Pump
Named without a submission number
—

What descends from it? (20)

See all 20

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061110Glucommander PlusCollaborativemed, LLC200616
K051041Insulin PumpAbbott Diabetes Care, Inc.20052

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 13, 2026Class IIZ-1748-2026Device DesignAll 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, 2007Not classifiedZ-1007-2007OtherExposure 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…

No ancestor or descendant has a 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 devices

LZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZG

2in 2024

2007: 32008: 62009: 22010: 22011: 42012: 32013: 22014: 42015: 12016: 42017: 12018: 12019: 22021: 12022: 12023: 12024: 22026 (partial year): 2
2007high 6 (2008) · low 0 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZG

116in 2016

2007: 112 days median2008: 129 days median2011: 189 days median2012: 73 days median2014: 123 days median2016: 116 days median
2007high 189 (2011) · low 73 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZG

1in 2022

2007: 12008: 132009: 22010: 42011: 22012: 42013: 3, 1 Class I2014: 2, 1 Class I2015: 2, 2 Class I2018: 3, 2 Class I2019: 52022: 1, 1 Class I2026 (partial year): 2, 2 Class I
2007high 13 (2008) · low 0 (2016)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · LZG

12,004in 2025

2007: 5,1102008: 5,7112009: 9,4712010: 10,1752011: 12,8582012: 18,3672013: 30,0592014: 49,1882015: 69,1362016: 56,5812017: 44,4722018: 32,6522019: 29,0272020: 32,5882021: 31,5222022: 28,2252023: 21,9722024: 18,2282025: 12,004
2007high 69,136 (2015) · low 5,110 (2007)2025

MAUDE reports naming product code LZG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007311215,110
20086129135,711
20092—29,471
20102—410,175
20114189212,858
2012373418,367
20132—3 (1)30,059
201441232 (1)49,188
20151—2 (2)69,136
20164116056,581
20171—044,472
20181—3 (2)32,652
20192—529,027
20200—032,588
20211—031,522
20221—1 (1)28,225
20231—021,972
20242—018,228
20250—012,004
20262—2 (2)—

What is it indicated for?

The Medtronic MiniMed Paradigm Model MMT-515/715 Insulin Pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Indications for use as stated in the FDA summary.

More from Medtronic Minimed

491 FDA decisions under this applicant name. See the company

  • P150001/S111Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROCMedtronic Minimed · 2026
  • P160007/S063Simplera System; Simplera SyncMedtronic Minimed · 2026
  • P160007/S060Simplera systemMedtronic Minimed · 2026
  • P160007/S062Simplera and Simplera SyncMedtronic Minimed · 2026
  • K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026

Recent decisions in LZG

The LZG category page

  • K262153Pivot Insulin Delivery SystemModular Medical, Inc. · 2026
  • K253534Pivot Insulin Delivery SystemModular Medical · 2026
  • K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
  • K241622Extended Reservoir; MiniMed ReservoirMedtronic Minimed · 2024
  • K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023

https://510kreport.com/device/K040676 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040676: Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040676

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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