510(k) Report

510(k) · Cleared

Cleared

Paradigm Insulin Infusion Pump, Models MMT-512, MMT-712, MMT-515 and MMT-715

K073356510(k) SpecialCleared Apr 25, 2008148-day reviewClass II21 CFR 880.5725

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 Apr 25, 2008 after a 148-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided
Apr 25, 2008
Review
148 days
Class
Class II
Product code
LZG
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2010: 1 descendant cleared20052010201520202025
  1. This deviceK073356 Paradigm Insulin Infusion Pump, Models MMT-512, MMT-712, MMT-515 and…Medtronic Minimed · 2008
  2. Descendant · cites it directly · 1 of its ownK090245 Solo Insulin Patch PumpMedingo, Ltd. · 2009
  3. Descendant · 2 generations on · 0 of its ownK093364 Solo Micropump Insulin Delivery SystemMedingo, Ltd. · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K090245Solo Insulin Patch PumpMedingo, Ltd. · 2009 · cites it directly1descendant
  • K093364Solo Micropump Insulin Delivery SystemMedingo, Ltd. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073356Paradigm Insulin Infusion Pump, Models MMT-512, MMT-712, MMT-515 and MMT-715Medtronic Minimed2008—
+1K090245Solo Insulin Patch PumpMedingo, Ltd.2009—
+2K093364Solo Micropump Insulin Delivery SystemMedingo, Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
FIG. 1 — Lineage of K073356, 2008–2010Source: 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?

The FDA summary names no predicate by number.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090245Solo Insulin Patch PumpMedingo, Ltd.20091

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K090245 (Medingo, Ltd., 2009) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.

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-512, MMT-712, MMT-515 and MMT-715 insulin infusion 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.

Cite this page

510(k) Report. “K073356: Paradigm Insulin Infusion Pump, Models MMT-512, MMT-712, MMT-515 and MMT-715.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073356

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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