# K120206: Medtronic Minimed Paradigm Insulin Pumps

- Pathway: 510(k) (Special)
- Applicant: Medtronic Minimed
- Decided: Mar 29, 2012 after 66 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 
- Jan 31, 2025 · Class II · Z-1255-2025: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be foun
- Jun 27, 2019 · Class II · Z-1586-2020: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorize
- Jun 27, 2019 · Class II · Z-1584-2020: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorize
- Jun 27, 2019 · Class II · Z-1583-2020: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorize
- Aug 7, 2018 · Class I · Z-0178-2020: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.

## Indications for use
The Paradigm Insulin Pump system is 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/K120206
Methodology: https://510kreport.com/methodology