510(k) Report

510(k) · Cleared

Cleared

Paradigmpal, Model MMT-7330

K031541510(k) TraditionalCleared Nov 18, 2003186-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

Minimed, Inc. · LZG Pump, Infusion, Insulin

Cleared on Nov 18, 2003 after a 186-day review. The FDA summary names its predicate without a number.

Decided
Nov 18, 2003
Review
186 days
Class
Class II
Product code
LZG
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K031541Source: FDA 510(k) database · 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
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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
*—Com-Link Communication System model 7304
Named without a submission number
—
*—Com-Link Communication System model 7311
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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.

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 ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting as a tool to save and adjust Medtronic MiniMed Paradigm pump settings using a personal computer.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K031541: Paradigmpal, Model MMT-7330.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031541

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026