# P120010: Minimed 530G System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Sep 26, 2013 after 478 days
- Product code: OZO (Automated Insulin Dosing , Threshold Suspend)
- Device class: 3
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 13, 2026 · Class II · Z-1751-2026: 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 
- Mar 13, 2014 · Class II · Z-2544-2014: Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.

Source page: https://510kreport.com/device/P120010
Methodology: https://510kreport.com/methodology