# Pediatric Hemodialysis System
> **Product code: QIR** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5861
## Classification
- **FDA Product Code:** QIR
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.5861
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## Definition

For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QIR)
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