# Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
> **Product code: OYC** · Class III — High Risk (PMA approval required, life-sustaining) · Unknown · —
## Classification
- **FDA Product Code:** OYC
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** —
- **Review panel:** CH
- **Medical specialty:** Unknown
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The insulin pump is intended to be used as a component of an invasive glucose device.  The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 6
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OYC)
---
*AI Analytics · CC0 1.0*