# K243607: Moda-flx Hemodialysis System™ Cartridge (102121-001 )

- Pathway: 510(k) (Special)
- Applicant: Diality, Inc.
- Decided: Dec 20, 2024 after 29 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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. The FDA summary names its predicate without a number.
- (no number) Moda-flx Hemodialysis System Cartridge: named in the summary without a submission number

## Indications for use
The Moda-fix Hemodialysis System TM Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-fix Hemodialysis System TM Cartridge is compatible only with the Moda-flx Hemodialysis System TM.

Source page: https://510kreport.com/device/K243607
Methodology: https://510kreport.com/methodology