# P150001: Minimed 630G System with Smartguard (TM)

- Pathway: PMA
- Applicant: Medtronic Minimed
- Decided: Aug 10, 2016 after 580 days
- Product code: OZO (Automated Insulin Dosing , Threshold Suspend)
- Device class: 3
- Recalls of this device: 10 (2 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 13, 2026 · Class II · Z-1740-2026: 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-1259-2025: 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
- Jul 31, 2024 · Class I · Z-0001-2025: Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the 
- Sep 20, 2022 · Class II · Z-0193-2023: Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. Th
- Jan 27, 2022 · Class II · Z-0855-2022: New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use
- Apr 30, 2020 · Class II · Z-0517-2021: Missing solder battery connection, which could interrupt power of insulin pump.
- Nov 21, 2019 · Class I · Z-0955-2020: There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock.
- Oct 3, 2018 · Class II · Z-0683-2019: Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications
- May 8, 2017 · Class II · Z-2603-2017: Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
- May 8, 2017 · Class II · Z-2602-2017: Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

Source page: https://510kreport.com/device/P150001
Methodology: https://510kreport.com/methodology