DeviceClearance

Product code QIR— Gastroenterology, Urology

CARPEDIEM System

Classification name
Pediatric Hemodialysis System
Device class
Class 2
Regulation
21 CFR 876.5861
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QIR under 21 CFR 876.5861, via openFDA

Market context for product code QIR

FDA has cleared 1 device under product code QIR, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QIR

Adverse events under product code QIR

product code QIR
Death
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QIR

Data sourced from openFDA. This site is unofficial and independent of the FDA.