# K192756: Aquadex FlexFlow System 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Chf Solutions, Inc.
- Decided: Feb 24, 2020 after 147 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: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K981681 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071854: Aquadex Flexflow System, Chf Solutions, Inc. (2007) Summary page 4.
- K171671: Prismaflex System 8.10, Baxter Healthcare Corporation (2018) Summary page 4.

## Recalls of this device
- Dec 11, 2024 · Class I · Z-0831-2025: The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in

## Indications for use
The Aquadex FlexFlow® System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.

Source page: https://510kreport.com/device/K192756
Methodology: https://510kreport.com/methodology