# K982340: Extracorporeal Blood Circuit

- Pathway: 510(k) (Traditional)
- Applicant: Haidylena Medical Egypt
- Decided: Apr 30, 1999 after 298 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
the device submitted in this premarket notification are intended for channeling blood during Haemodialysis Treatement.

Source page: https://510kreport.com/device/K982340
Methodology: https://510kreport.com/methodology