# K021615: Baxter Accura System, Model 5M5660

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Nov 18, 2002 after 186 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910215 (1991). 16 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993064: Prisma CFM (Continuous Fluid Management System), Gambro Renal Care Products (1999) Summary page 1.
- K981681: Prisma CFM (Continuous Fluid Management System), Gambro Healthcare (1998) Summary page 1.
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997) Summary page 1.
- K973322: Diapact CRRT, B.Braun Medical, Inc. (1998) Summary page 1.
- K911315: Extracorporeal Blood Pumping Syst for Hemofiltrat, Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets (2004), 4 descendants of its own
- K080519: Prismaflex M150 Set (2008), 1 descendant of its own
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01 (2007), 1 descendant of its own
- K042938: Gambro Prismaflex HF1000 and HF1400 Sets (2005), 1 descendant of its own
- K220281: multiFiltratePRO System (2022), 0 descendants of its own

## Recalls of this device
- Aug 29, 2005 · Not classified · Z-0153-06: A software anomaly that occurs when the Reset Totals option is selected during CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less t
- Jul 13, 2005 · Not classified · Z-1380-05: In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upo
- Jul 26, 2004 · Not classified · Z-1338-04: The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen,

## Indications for use
The Baxter Accura System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Baxter Accura System may also be used in Therapeutic Plasma Exchange (TPE) therapies.

Source page: https://510kreport.com/device/K021615
Methodology: https://510kreport.com/methodology