# P140015: T:Slim G4 Insulin Pump with Dexcom G4 Platinum CGM

- Pathway: PMA
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Sep 8, 2015 after 418 days
- Product code: OYC (Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor)
- 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
- Apr 23, 2018 · Class II · Z-2471-2018: The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction

Source page: https://510kreport.com/device/P140015
Methodology: https://510kreport.com/methodology