# P120005: Dexcom G4 Platinum Contiuous Glucose Monitoring System

- Pathway: PMA
- Applicant: Dexcom, Inc.
- Decided: Oct 5, 2012 after 179 days
- Product code: MDS (Sensor, Glucose, Invasive)
- 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 3, 2020 · Class II · Z-1560-2020: The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
- Feb 3, 2020 · Class II · Z-1561-2020: The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.

Source page: https://510kreport.com/device/P120005
Methodology: https://510kreport.com/methodology