# K984022: Pediatric Two-Lumen Hemodialysis Catherization Kit

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: May 18, 1999 after 187 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has 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) ARROW Large-Bore Dual Lumen Hemodialysis Catheterization Kit: named in the summary without a submission number

## Most influential descendants
- K020936: 10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash Split-Cath XL, Model ASPC24P-XL (2002), 3 descendants of its own
- K200627: GlidePath 10F Long-Term Dialysis Catheter (2020), 2 descendants of its own
- K202150: GlidePath 7.5F Long-Term Dialysis Catheter (2020), 1 descendant of its own
- K241581: Hemodialysis Catheter (2025), 0 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2373-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect

## Indications for use
The dual-lumen hemodialysis catheter permits venous access to the central circulation system for rapid fluid administration, temporary or acute hemodialysis and apheresis . It may be inserted into the jugular, subclavian, or femoral veins of children, adolescents and small adults.

Source page: https://510kreport.com/device/K984022
Methodology: https://510kreport.com/methodology