# P160007: Guardian Connect system

- Pathway: PMA
- Applicant: Medtronic Minimed
- Decided: Mar 8, 2018 after 730 days
- Product code: MDS (Sensor, Glucose, Invasive)
- Device class: 3
- Recalls of this device: 3 (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
- May 7, 2025 · Class II · Z-0033-2026: The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
- May 20, 2019 · Class II · Z-2106-2020: Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitte
- Jul 4, 2018 · Class II · Z-1282-2019: The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could

Source page: https://510kreport.com/device/P160007
Methodology: https://510kreport.com/methodology