# K063293: Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set;  Edwards Aquaspike and Aquasafe

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences Services GmbH
- Decided: Mar 23, 2007 after 142 days
- Product code: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910215 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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 2.
- K911315: Extracorporeal Blood Pumping Syst for Hemofiltrat, Baxter Healthcare Corp (1991) Summary page 2.
- K032431: Prisma M60/M100 Sets, Gambro, Inc. (2003) Summary page 2.

## Indications for use
The Edwards Aqualine Tubing Set is indicated for use with the Baxter Accura System for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Set may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aqualine Tubing Sets are indicated for use in a clinical setting and not for home use. The Edwards Aqualine S Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired. The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and /or fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.

Source page: https://510kreport.com/device/K063293
Methodology: https://510kreport.com/methodology