# K024124: System 100-UF 500 Circuit with in-Line Needleless Access Port

- Pathway: 510(k) (Traditional)
- Applicant: Chf Solutions, Inc.
- Decided: Mar 14, 2003 after 88 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942988 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013733: System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set, Chf Solutions, Inc. (2002) Summary page 1.
- K955585: V2 Injection Site, B.Braun Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K023874: System 100 Ultrafiltration Catheter (2003), 0 descendants of its own

## Indications for use
For use with the System 100. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload. The UF500 blood circuit with needleless access port allows for aspiration, injection, or gravity flow of fluids using a male luer fitting.

Source page: https://510kreport.com/device/K024124
Methodology: https://510kreport.com/methodology