# K030099: Baxter Arena Hemodialysis Delivery System, Model 1571278000

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 17, 2003 after 158 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 21, 2006 · Not classified · Z-1253-06: The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.
- Nov 18, 2005 · Not classified · Z-0347-06: Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air embo
- Jun 14, 2005 · Not classified · Z-1395-05: Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Ad
- Dec 14, 2004 · Not classified · Z-0367-05: Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
- Feb 20, 2004 · Not classified · Z-0584-04: These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.

## Indications for use
The Baxter Arena™ Hemodialysis Delivery System is indicated for use when a hollow fiber dialyzer is chosen for use in chronic or acute hemodialysis treatments, including high flux hemodialysis. All therapies using the Arena Hemodialysis Delivery System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about renal replacement therapies and the treatment is performed in an in-clinic environment and supervised by trained healthcare professionals. The Arena Hemodialysis Delivery System is not designed, sold or intended for any use except as indicated above. Furthermore, it is not intended to be used outside the device specifications or limitations.

Source page: https://510kreport.com/device/K030099
Methodology: https://510kreport.com/methodology