510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN180055Unknown

CARPEDIEM System

Bellco SRL (Now Part of Medtronic, Inc), Mirandola, IT / Direct, Unknown
FDA source (opens on fda.gov)

DEN180055 is the FDA 510(k) clearance record for CARPEDIEM System, a class II device, cleared for Bellco Srl (Now Part of Medtronic, Inc) on under FDA product code QIR (Pediatric Hemodialysis System). FDA's definition for product code QIR 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". FDA records list one 510(k) clearance for Bellco Srl (Now Part of Medtronic, Inc). As of , FDA records show no recalls naming DEN180055.

Clearance record

Decision date
Received
(568 days to decision)
Product code
QIR Pediatric Hemodialysis System
Regulation
21 CFR 876.5861
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bellco Srl (Now Part of Medtronic, Inc) Via Camurana 1, Mirandola, IT
Third party review
No

Clearances, product code QIR

Trailing 12 months

FDA records hold no clearances under product code QIR in the trailing twelve months.

FDA records show no clearances under product code QIR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260