# Insulin Pump Secondary Display
> **Product code: PKU** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1350
## Classification
- **FDA Product Code:** PKU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1350
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PKU)
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