# DEN180055: CARPEDIEM System

- Pathway: De Novo (Direct)
- Applicant: Bellco Srl (Now Part of Medtronic, Inc)
- Decided: Apr 29, 2020 after 568 days
- Product code: QIR (Pediatric Hemodialysis System)
- Device class: 2
- Regulation: 21 CFR 876.5861
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The CARPEDIEM System is indicated 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.

Source page: https://510kreport.com/device/DEN180055
Methodology: https://510kreport.com/methodology