# K031390: Medtronic Minimed Paradigm Insulin Pump, Model MMT-712

- Pathway: 510(k) (Traditional)
- Applicant: Minimed, Inc.
- Decided: Jul 23, 2003 after 82 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
40 later devices descend from it; 1 cites it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic MiniMed Paradigm Model 511 Insulin Pump: named in the summary without a submission number

## Most influential descendants
- K042887: Accu-Chek Spirit (2005), 39 descendants of its own
- K060876: Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa (2006), 38 descendants of its own
- K111353: Accu-Check Combo System (2012), 37 descendants of its own
- K141929: Accu-Chek Connect Diabetes Management App (2015), 33 descendants of its own
- K150910: ACCU-CHEK Connect Diabetes Management App (2015), 32 descendants of its own

## Recalls of this device
- Feb 13, 2026 · Class II · Z-1748-2026: 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 
- Apr 27, 2007 · Not classified · Z-1007-2007: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K031390
Methodology: https://510kreport.com/methodology