# P130007: Animas Vibe System

- Pathway: PMA
- Applicant: Animas Corp.
- Decided: Nov 25, 2014 after 587 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
- Sep 6, 2011 · Class II · Z-1034-2015: Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pum

Source page: https://510kreport.com/device/P130007
Methodology: https://510kreport.com/methodology