# P150019: Paradigm Real-Time Revel System

- Pathway: PMA
- Applicant: Medtronic Minimed
- Decided: Dec 7, 2015 after 180 days
- Product code: MDS (Sensor, Glucose, Invasive)
- Device class: 3
- Recalls of this device: 1 (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-1750-2026: 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 

Source page: https://510kreport.com/device/P150019
Methodology: https://510kreport.com/methodology