FDA product code QIR: Pediatric Hemodialysis System
QIR is the FDA product code for pediatric hemodialysis system. It is a Class II device, regulated under 21 CFR 876.5861 and reviewed by the Gastroenterology and Urology panel. Devices under QIR reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Pediatric Hemodialysis System |
| Device class | Class II |
| Regulation | 21 CFR 876.5861 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for QIR devices
openFDA lists no recalls for product code QIR.
Frequently asked questions
What is FDA product code QIR?
QIR is the FDA product code for pediatric hemodialysis system. It is a Class II device, regulated under 21 CFR 876.5861 and reviewed by the Gastroenterology and Urology panel.
What device class is QIR?
Class II, regulation 21 CFR 876.5861. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QIR
- Run a recall and safety report across every QIR manufacturer
- Watch product code QIR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times