# K040489: Aquadex System 100, Model A1100

- Pathway: 510(k) (Special)
- Applicant: Chf Solutions, Inc.
- Decided: Apr 27, 2004 after 61 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 K981681 (1998). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has 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.
- K981681: Prisma CFM (Continuous Fluid Management System), Gambro Healthcare (1998) Summary page 1.

## Most influential descendants
- K050609: Aquadex System (2005), 5 descendants of its own
- K060008: Aquadex Flexflow System (2006), 4 descendants of its own
- K062922: Modification to Aquadex Flexflow System (2006), 3 descendants of its own
- K070512: Modification to Aquadex Flexflow System (2007), 2 descendants of its own
- K071854: Aquadex Flexflow System (2007), 1 descendant of its own

## Indications for use
The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

Source page: https://510kreport.com/device/K040489
Methodology: https://510kreport.com/methodology