# K023874: System 100 Ultrafiltration Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Chf Solutions, Inc.
- Decided: Nov 20, 2003 after 364 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: 3 generations back to K981681 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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)
- K023224: Infusion Catheter Extension Set, Chf Solutions, Inc. (2002) Summary page 1.
- K024124: System 100-UF 500 Circuit with in-Line Needleless Access Port, Chf Solutions, Inc. (2003). Cleared while this submission was under review
- K981681: Prisma CFM (Continuous Fluid Management System), Gambro Healthcare (1998) Summary page 1.
- K974236: Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL Soft-Line Double Lumen Catheter, 20CM SB, Medical Components, Inc. (1999) Summary page 1.

## Indications for use
In association with central venous access: 1) The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload. 2) The dual lumen ultrafiltration catheter [A15371 is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100. (INSERTION SITES) The dual lumen ultrafiltration catheter may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian or femoral veins as required. Use should be limited to areas within the hospital where patients with a central venous catheter are routinely managed. 3) The catheter extension [A15131 may also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits. 4) The System 100 S-100 console [A11001 may be used when either peripheral or central venous access is employed. 5) The UF 500 circuit [A1500 and A15501 may be used when either peripheral or central venous access is employed.

Source page: https://510kreport.com/device/K023874
Methodology: https://510kreport.com/methodology