# K070320: Edwards Aquarius Hemofiltration System, Model Abm 01

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences Services GmbH
- Decided: Jun 7, 2007 after 125 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 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910215 (1991). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021615: Baxter Accura System, Model 5M5660, Baxter Healthcare Corp (2002) Summary page 3.
- K993064: Prisma CFM (Continuous Fluid Management System), Gambro Renal Care Products (1999) Summary page 3.
- K981681: Prisma CFM (Continuous Fluid Management System), Gambro Healthcare (1998) Summary page 3.
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997) Summary page 3.
- K973322: Diapact CRRT, B.Braun Medical, Inc. (1998) Summary page 3.

## Most influential descendants
- K090682: Edwards Aquarius System, Model GE-F098-00 (2009), 0 descendants of its own

## Recalls of this device
- Mar 16, 2009 · Not classified · Z-0653-2010: There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the Aquarius will trigger an alarm, however, users are able to override this alarm

## 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/K070320
Methodology: https://510kreport.com/methodology