# K013733: System 100; S-100 Ultrafiltration Console; BDT 500 Ultrafiltration Set

- Pathway: 510(k) (Traditional)
- Applicant: Chf Solutions, Inc.
- Decided: Jun 3, 2002 after 206 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: 1 generation back to K981681 (1998). 1 ancestor in all.
14 later devices descend from it; 6 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981681: Prisma CFM (Continuous Fluid Management System), Gambro Healthcare (1998) Summary page 1.
- (no number) PRISMA M60 Set: named in the summary without a submission number

## Most influential descendants
- K040489: Aquadex System 100, Model A1100 (2004), 6 descendants of its own
- 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
- K031689: Dual Lumen Extended Length Catheter (Delc) (2003), 3 descendants of its own

## Indications for use
System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

Source page: https://510kreport.com/device/K013733
Methodology: https://510kreport.com/methodology