# K040676: Medtronic Minimed Paradigm Insulin Pump, Models MMT-515 and MMT-715

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: May 21, 2004 after 67 days
- Product code: LZG (Pump, Infusion, Insulin)
- 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.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have 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 512 Insulin Pump: named in the summary without a submission number
- (no number) Medtronic MiniMed Paradigm Model 712 Insulin Pump: named in the summary without a submission number

## Most influential descendants
- K061110: Glucommander Plus (2006), 16 descendants of its own
- K101344: G+ System (2010), 13 descendants of its own
- K113853: G+ System (2012), 12 descendants of its own
- K132547: Endo Tool Glucose Management System (Egms) (2014), 8 descendants of its own
- K200443: EndoTool IV 1.10 (2020), 3 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 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.

Source page: https://510kreport.com/device/K040676
Methodology: https://510kreport.com/methodology