# K992039: Exel I.V. Blood Line Set

- Pathway: 510(k) (Traditional)
- Applicant: Exelint Intl. Co.
- Decided: Feb 10, 2000 after 238 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
THIS HEMODIALYSIS BLOOD LINE SET IS CONNECTED TO THE PATIENT AS A DEVICE WHICH WILL EXTRACT THE BLOOD TO THE ARTIFICIAL ORGAN AND PUMPED BACK TO THE PATIENT.

Source page: https://510kreport.com/device/K992039
Methodology: https://510kreport.com/methodology