# K090682: Edwards Aquarius System, Model GE-F098-00

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences Services GmbH
- Decided: Nov 19, 2009 after 248 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: 6 generations back to K910215 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01, Edwards Lifesciences Services GmbH (2007) Summary page 2.

## Indications for use
The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.

Source page: https://510kreport.com/device/K090682
Methodology: https://510kreport.com/methodology