# K060008: Aquadex Flexflow System

- Pathway: 510(k) (Special)
- Applicant: Chf Solutions, Inc.
- Decided: Feb 2, 2006 after 30 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: 4 generations back to K981681 (1998). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050609: Aquadex System, Chf Solutions, Inc. (2005)
- K982412: Modification of Crit-Line Monitor Iii (CLM Iii), In-Line Diagnostics Corp. (1998) Summary page 1.
- K011741: Crit-Line Monitor Iii Tqa (CLM Tqa), Hemametrics (2002) Summary page 1.

## Most influential descendants
- 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
- K192756: Aquadex FlexFlow System 2.0 (2020), 0 descendants of its own

## Indications for use
The Aquadex FlexFlowTM System is indicated for: * Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and * Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.

Source page: https://510kreport.com/device/K060008
Methodology: https://510kreport.com/methodology