510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QIRClass II

Pediatric Hemodialysis System

21 CFR 876.5861 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QIR is the FDA product code for Pediatric Hemodialysis System, a class II device type, regulated under 21 CFR 876.5861. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QIR
Device name
Pediatric Hemodialysis System
FDA 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.
Regulation
21 CFR 876.5861
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QIR

By decision year
1 clearance under product code QIR with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QIR by decision year
YearClearances
20201

Applicants with the most clearances

Product code QIR
Applicants holding the most 510(k) clearances under product code QIR
ApplicantClearances
Bellco SRL (Now Part of Medtronic, Inc)1

Companies listing this code with FDA

Companies whose registered establishments list this code